Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Section

320.01: General Provisions 320.02: Definitions 320.03: Covered and Excluded Billing Situations 320.04: General Rate Provisions and Maximum Fees 320.05: Allowable Fees 320.06: Filing and Reporting Requirements 320.07: Severability

320.01: General Provisions

(1) Scope and Purpose. 101 CMR 320.00 governs the payment rates for clinical laboratory services rendered to publicly aided individuals. The rates set forth in 101 CMR 320.00 do not apply to individuals covered by M.G.L. c. 152 (the Workers’ Compensation Act). Rates for services rendered to such individuals are set forth in 114.3 CMR 40.00: Rates for Services Under M.G.L. c. 152, Worker’s Compensation Act.

(2) Applicable Dates of Service. Rates contained in 101 CMR 320.00 apply for dates of service provided on or after January 1, 2021.

(3) Coverage. The payment rates in 101 CMR 320.00 are full compensation for clinical laboratory services rendered to publicly aided individuals.

(4) Coding Updates and Corrections. EOHHS may publish procedure code updates and corrections in the form of an administrative bulletin. Updates may reference coding systems including but not limited to the American Medical Association’s Current Procedural Terminology (CPT). The publication of such updates and corrections lists (a) codes for which only the code numbers changed, with the corresponding cross-references between existing and new codes; (b) deleted codes for which there are no corresponding new codes; and (c) codes for entirely new services that require pricing. EOHHS may list and price these codes according to the rate methodology used in setting clinical laboratory rates when Medicare fees are available (including, for codes relating to Coronavirus Disease 2019 (COVID-19), at 100% of Medicare fees). When Medicare fees are not available, EOHHS may apply individual consideration (I.C.) in reimbursing for these codes until appropriate rates can be developed.

(5) Administrative Bulletins. EOHHS may issue administrative bulletins to clarify its policy on and understanding of substantive provisions of 101 CMR 320.00.

(6) Disclaimer of Authorization of Services. 101 CMR 320.00 is neither authorization for nor approval of the substantive services for which rates are determined pursuant to 101 CMR 320.00. governmental units that purchase care are responsible for the definition, authorization, and approval of care and services extended to publicly aided individuals.

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101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

320.02: Definitions

As used in 101 CMR 320.00, terms have the meanings ascribed in 101 CMR 320.02.

Allowable Fee. The amount of reimbursement that is paid by all governmental units for a laboratory service, as set forth in 101 CMR 320.04 and 101 CMR 320.05.

Bulk Purchase. A single purchase of a laboratory service (one or more tests) to be uniformly and concurrently performed on a minimum of 40 specimens of the same type. A single purchase of various, non-uniform laboratory services, such as by a physician, is not considered a bulk purchase, regardless of the number of specimens presented by such a purchaser to the laboratory.

Charge. The price of a laboratory service as determined by the clinical laboratory performing the service.

Clinical Laboratory. A laboratory where microbiological, chemical, hematological, biophysical, cytological, immuno-hematological, or pathological examinations are performed on materials derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

Center. The Center for Health Information and Analysis established under M.G.L. c. 12C.

Eligible Provider of Laboratory Services. A person licensed by an appropriate Board of Registration to perform clinical laboratory services, such registration being in accordance with the provisions of M.G.L. c. 112; or an independent laboratory. Such persons and laboratories must meet all conditions of participation that have been or may be adopted by a governmental unit that purchases laboratory services. For purposes of 101 CMR 320.00, eligible providers of laboratory services do not include hospital laboratories.

EOHHS. The Executive Office of Health and Human Services established under M.G.L. c. 6A.

Fee Schedule. (Description of Service and HCPCS/CPT-4 Procedure Code). HCFA Common Procedure Coding System (HCPCS), which is based upon the American Medical Association (AMA) CPT-4, is the basis by which all procedures are performed. The CPT-4 handbook is updated by the AMA annually. All non-physician codes and terminology is defined by the Health Care Financing Administration (HCFA) and set forth in the HCPCS file.

Governmental Unit. The Commonwealth, any department, division, agency, board, or commission of the Commonwealth and any political subdivision of the Commonwealth.

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101 CMR 320.00: CLINICAL LABORATORY SERVICES

Independent Clinical Laboratory. A clinical laboratory that is operated independently from a hospital or from an attending or consulting physician's office. If the laboratory is operated or directed by one or more licensed physicians, it must offer its services to other physicians to qualify as an independent clinical laboratory. In cases where two or more distinct, physically separated laboratory facilities operate under the same name and the same director, each facility that performs clinical laboratory services is treated as a separate independent clinical laboratory.

Profile (or Panel) Tests. Any group of tests, whether performed manually, automated, or semi- automated, that is ordered for a specific patient on a specified day, and has at least one of the following characteristics. (a) The group of tests is designated as a profile or panel by the clinical laboratory performing the tests. (b) The group of tests is performed by the clinical laboratory and the customary charge is less than the sum of that clinical laboratory's usual and customary charges for the individual tests in that group.

Publicly Aided Individual. A person who receives medical care and services for which a governmental unit is liable, in whole or in part, under a statutory program of public assistance.

Rate. The lesser of the charge or the allowable fee, as defined in 101 CMR 320.02.

Usual and Customary Charge. The lowest fee charged by an independent clinical laboratory for any laboratory service (including individual and profile tests) specified by 101 CMR 320.00 or by such independent clinical laboratory, which fee is in effect at the time such laboratory service is performed, other than a fee offered for a bulk purchase, as defined in 101 CMR 320.02.

320.03: Covered and Excluded Billing Situations

(1) Covered Billing Situations. Except as provided in 101 CMR 320.03(2), the method of determining rates of payment contained in 101 CMR 320.00 apply to clinical laboratory services provided to publicly aided individuals, with the following conditions. (a) If clinical laboratory services are performed by an Independent clinical laboratory, then the independent clinical laboratory must bill the governmental unit directly. The independent clinical laboratory may not bill indirectly by having a physician or dentist bill either the payer or the patient for services performed by the independent clinical laboratory. (b) If clinical laboratory services are performed by a registered physician or dentist, or by an agent under his or her direct supervision, in his or her private medical office or clinic, then the registered physician or dentist must bill the governmental unit directly.

(2) Excluded Billing Situations. 101 CMR 320.00 and the rates of payment contained in 101 CMR 320.00 do not govern the rates of payment for clinical laboratory services if (a) the service is provided in state institutions by a state-employed physician, dentist, or dentist consultant;

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101 CMR 320.00: CLINICAL LABORATORY SERVICES

(b) the service is provided by a physician or dentist whose salary from a hospital or affiliated medical school includes compensation for professional services rendered to patients; or (c) the physician, dentist, or independent laboratory does not customarily bill private patients without health insurance under comparable circumstances.

(3) Professional and Technical Component Services. Some laboratory services have both professional and technical components. The professional component is set forth in 101 CMR 316.00: Surgery and Anesthesia Services, while the technical component is set forth in 101 CMR 320.00. (a) The relevant codes for laboratory services containing both professional and technical components are 83020, 84165, 84166, 84181, 84182, 85390, 85576, 86153, 86255, 86256, 86320, 86325, 86327, 86334, 86335, 87164, 87207, and 89060. (b) Surgical pathology services are excluded from 101 CMR 320.00 and instead included in 101 CMR 316.00: Surgery and Anesthesia Services. Surgical pathology services include codes 80500, 80502, 85060, 85097, 85396, 86077, 86078, 86079, 86486, 86490, 86510, 86580, 88104, 88106, 88108, 88112, 88120, 88121, 88125, 88141, 88160, 88161, 88162, 88172, 88173, 88177, 88182, 88184, 88185, 88187, 88188, 88189, 88199, 88291, 88299, 88300, 88302, 88304, 88305, 88307, 88309, 88311, 88312, 88313, 88314, 88319, 88321, 88323, 88325, 88329, 88331, 88332, 88333, 88334, 88341, 88344, 88346, 88348, 88350, 88355, 88356, 88358, 88360, 88361, 88362, 88363, 88365, 88366, 88367, 88368, 88369, 88374, 88375, 88377, 88380, 88381, 88387, 88388, 88399, 89049, 89060, 89220, 89230, and 89240.

320.04: General Rate Provisions and Maximum Fees

(1) Rate Determination. Payment rates are the lowest of (a) the eligible provider's usual and customary charge to patients other than publicly aided individuals or industrial accident patients; (b) the applicable listing from the schedule of allowable fees listed in 101 CMR 320.05; or (c) the amount that is allowable under 42 U.S.C. § 1396b(i)(7).

(2) Individual Consideration (I.C.). Unlisted procedures and laboratory tests designated I.C. are individually considered items. The eligible provider's bill for such a test must be accompanied by a brief report of the procedure or test performed and the eligible provider's usual and customary charge for that procedure or test. Determination of appropriate payments for procedures and tests designated I.C. are in accordance with the following standards and criteria: (a) time required to perform the procedure; (b) degree of skill required in the procedure performed; (c) severity or complexity of the patient's disease, disorder, or disability; (d) policies, procedures, and practices of other third party purchasers of care; (e) prevailing medical-laboratory ethics and accepted custom of the medical-laboratory community; and (f) such other standards and criteria as may be adopted by EOHHS. In no event may an eligible provider bill or be paid in excess of the usual and customary charge for the service.

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(3) Administrative and Supervisory Duties. The rates of payment under 101 CMR 320.00 are full compensation for clinical laboratory services rendered to publicly aided individuals, as well as any related administrative or supervisory duties in connection with clinical laboratory services, without regard to where the service is rendered.

(4) Profile (or Panel) Tests. In no event may an eligible provider bill or be paid separately for each of the tests included within a profile test when a profile test has either been performed by the provider or requested by an authorized person.

(5) Limitations on Payment for Panel Tests. (a) Any combination of the following tests when performed on a single patient on a single date of service is regarded as a single panel test: 80047 Basic Metabolic Panel -calcium, ionized (Consists of 82330, 82374, 82435, 82565, 82947, 84132, 84295, 84520): eight individual tests 80048 Basic Metabolic Panel -calcium, total (Consists of 82310, 82374, 82435, 82565, 82947, 84132, 84295, 84520): eight individual tests 80051 Electrolyte Panel (Consists of 82374, 82435, 84132, 84295): four individual tests 80053 Comprehensive Metabolic Panel (Consists of 82040, 82247, 82310, 82374, 82435, 82565, 82947, 84075, 84132, 84155, 84295, 84460, 84450, 84520): 14 individual tests 80061 Lipid Panel (Consists of 82465, 83718, 84478): three individual tests 80069 Renal Function Panel (Consists of 82040, 82310, 82374, 82435, 82565, 82947, 84100, 84132, 84295, 84520): ten individual tests 80076 Hepatic Function Panel (Consists of 82040, 82247, 82248, 84075, 84155, 84460, 84450): seven individual tests 82040 Albumin; serum 82247 Bilirubin; total 82248 Bilirubin; direct 82310 Calcium; total 82374 Carbon dioxide (bicarbonate) 82435 Chloride; blood 82465 Cholesterol, serum or whole blood, total 82550 Creatine kinase (CK), (CPK); total 82565 Creatinine; blood 82947 Glucose; quantitative 82977 Glutamyltransferase, gamma (GGT) 83615 Lactate dehydrogenase (LD), (LDH) 84075 Phosphatase, alkaline 84100 Phosphorus, inorganic (phosphate) 84132 Potassium; serum, plasma or whole blood 84155 Protein, total, except refractometry 84295 Sodium; serum, plasma or whole blood 84450 Transferase; aspatrate amino (AST) (SGOT) 84460 Transferase; alanine amino (ALT) (SGPT) 84478 Triglycerides

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101 CMR 320.00: CLINICAL LABORATORY SERVICES

84520 Urea nitrogen; quantitative 84550 Uric acid; blood (b) Panel tests are reimbursed according to the following schedule. Code Rate Description ATP02 $5.37 Auto Test Panel Pricing Code, 1-2 Tests ATP03 $6.85 Auto Test Panel Pricing Code, 3 Tests ATP04 $7.24 Auto Test Panel Pricing Code, 4 Tests ATP05 $8.06 Auto Test Panel Pricing Code, 5 Tests ATP06 $8.08 Auto Test Panel Pricing Code, 6 Tests ATP07 $8.43 Auto Test Panel Pricing Code, 7 Tests ATP08 $8.73 Auto Test Panel Pricing Code, 8 Tests ATP09 $8.96 Auto Test Panel Pricing Code, 9 Tests ATP10 $8.96 Auto Test Panel Pricing Code, 10 Tests ATP11 $9.11 Auto Test Panel Pricing Code, 11 Tests ATP12 $9.30 Auto Test Panel Pricing Code, 12 Tests ATP13 $10.89 Auto Test Panel Pricing Code, 13 Tests ATP14 $10.89 Auto Test Panel Pricing Code, 14 Tests ATP15 $10.89 Auto Test Panel Pricing Code, 15 Tests ATP16 $10.89 Auto Test Panel Pricing Code, 16 Tests ATP17 $10.97 Auto Test Panel Pricing Code, 17 Tests ATP18 $10.97 Auto Test Panel Pricing Code, 18 Tests ATP19 $11.41 Auto Test Panel Pricing Code, 19 Tests ATP20 $11.78 Auto Test Panel Pricing Code, 20 Tests ATP21 $12.15 Auto Test Panel Pricing Code, 21 Tests ATP22 $12.51 Auto Test Panel Pricing Code, 22 Tests ATP23 $12.51 Auto Test Panel Pricing Code, 23 or more Tests

320.05: Allowable Fees

Code Rate Description Organ and Disease Oriented Panels Basic metabolic panel (Calcium, ionized) This panel must include the following: Calcium, ionized (82330) Carbon dioxide (bicarbonate) (82374) Chloride 80047 $10.14 (82435) Creatinine (82565) Glucose (82947) Potassium (84132) Sodium (84295) Urea nitrogen (BUN) (84520)

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101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Basic metabolic panel (Calcium, total) This panel must include the following: Calcium, total (82310) Carbon 80048 $7.71 dioxide (bicarbonate) (82374) Chloride (82435) Creatinine (82565) Glucose (82947) Potassium (84132) Sodium (84295) Urea nitrogen (BUN) (84520) General health panel This panel must include the following: Comprehensive metabolic panel (80053) Blood count, complete (CBC), automated and automated differential WBC count (85025 or 85027 80050 $16.94 and 85004) OR Blood count, complete (CBC), automated (85027) and appropriate manual differential WBC count (85007 or 85009) Thyroid stimulating hormone (TSH) (84443) Electrolyte panel This panel must include the 80051 $6.40 following: Carbon dioxide (bicarbonate) (82374) Chloride (82435) Potassium (84132) Sodium (84295) Comprehensive metabolic panel This panel must include the following: Albumin (82040) Bilirubin, total (82247) Calcium, total (82310) Carbon dioxide (bicarbonate) (82374) Chloride (82435) Creatinine 80053 $9.63 (82565) Glucose (82947) Phosphatase, alkaline (84075) Potassium (84132) Protein, total (84155) Sodium (84295) Transferase, alanine amino (ALT) (SGPT) (84460) Transferase, aspartate amino (AST) (SGOT) (84450) Urea nitrogen (BUN) (84520) Obstetric panel This panel must include the following: Blood count, complete (CBC), automated and automated differential WBC count (85025 or 85027 and 85004) OR Blood count, complete (CBC), automated (85027) and appropriate manual differential 80055 $43.61 WBC count (85007 or 85009) Hepatitis B surface antigen (HBsAg) (87340) Antibody, rubella (86762) Syphilis test, non-treponemal antibody; qualitative (e.g., VDRL, RPR, ART) (86592) Antibody screen, RBC, each serum technique (86850) Blood typing, ABO (86900) AND Blood typing, Rh (D) (86901) Lipid panel This panel must include the following: Cholesterol, serum, total (82465) Lipoprotein, direct 80061 $12.21 measurement, high density cholesterol (HDL cholesterol) (83718) Triglycerides (84478)

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Code Rate Description Renal function panel This panel must include the following: Albumin (82040) Calcium, total (82310) Carbon dioxide (bicarbonate) (82374) Chloride 80069 $7.92 (82435) Creatinine (82565) Glucose (82947) Phosphorus inorganic (phosphate) (84100) Potassium (84132) Sodium (84295) Urea nitrogen (BUN) (84520) Acute hepatitis panel This panel must include the following: Hepatitis A antibody (HAAb), IgM 80074 $43.45 antibody (86709) Hepatitis B core antibody (HBcAb), IgM antibody (86705) Hepatitis B surface antigen (HBsAg) (87340) Hepatitis C antibody (86803) Hepatic function panel This panel must include the following: Albumin (82040) Bilirubin, total (82247) Bilirubin, direct (82248) Phosphatase, alkaline (84075) 80076 $7.46 Protein, total (84155) Transferase, alanine amino (ALT) (SGPT) (84460) Transferase, aspartate amino (AST) (SGOT) (84450) 80081 $68.29 Obstetric panel (includes HIV testing) Drug Testing and Therapeutic Assays 80145 $28.50 Adalimumab 80150 $13.75 Amikacin 80155 $28.50 Caffeine 80156 $13.28 Carbamazepine; total 80157 $12.09 Carbamazepine; free 80158 $16.46 Cyclosporine 80159 $16.87 Clozapine 80162 $12.11 Digoxin; total 80163 $12.11 Digoxin; free 80164 $12.35 Valproic acid (dipropylacetic acid); total 80165 $12.35 Valproic acid (dipropylacetic acid); free 80168 $14.90 Ethosuximide 80169 $12.53 Everolimus 80170 $14.94 Gentamicin 80171 $16.01 Gabapentin, whole blood, serum, or plasma 80173 $13.28 Haloperidol 80175 $12.09 Lamotrigine 80176 $13.40 Lidocaine 80177 $12.09 Levetiracetam 80178 $6.03 Lithium

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101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description 80180 $16.46 Mycophenolate (mycophenolic acid) 80183 $12.09 Oxcarbazepine 80184 $11.30 Phenobarbital 80185 $12.09 Phenytoin; total 80186 $12.55 Phenytoin; free 80187 $20.03 Posaconazole 80188 $15.13 Primidone 80190 $44.33 Procainamide Procainamide; with metabolites (e.g., n-acetyl 80192 $15.28 procainamide) 80194 $13.32 Quinidine 80195 $12.53 Sirolimus 80197 $12.53 Tacrolimus 80198 $12.90 Theophylline 80199 $20.03 Tiagabine 80200 $14.71 Tobramycin 80201 $10.88 Topiramate 80202 $12.35 Vancomycin 80203 $12.09 Zonisamide 80230 $28.50 Infliximab 80235 $20.03 Lacosamide 80280 $28.50 Vedolizumab Evocative Suppression Testing Quantitation of therapeutic drug, not elsewhere 80299 $13.77 specified Drug test(s), presumptive, any number of drug classes, any number of devices or procedures; capable of being read by direct optical observation only (e.g., utilizing 80305 $8.92 immunoassay [e.g., dipsticks, cups, cards, or cartridges]), includes sample validation when performed, per date of service Drug test(s), presumptive, any number of drug classes, any number of devices or procedures; read by instrument-assisted direct optical observation (e.g., 80306 $11.89 utilizing immunoassay [e.g., dipsticks, cups, cards, or cartridges]), includes sample validation when performed, per date of service

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101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Drug test(s), presumptive, any number of drug classes, any number of devices or procedures; by instrument chemistry analyzers (e.g., utilizing immunoassay [e.g., EIA, ELISA, EMIT, FPIA, IA, KIMS, RIA]), 80307 $47.55 chromatography (e.g., GC, HPLC), and mass spectrometry either with or without chromatography, (e.g., DART, DESI, GC-MS, GC-MS/MS, LC-MS, LC-MS/MS, LDTD, MALDI, TOF) includes sample validation when performed, per date of service ACTH stimulation panel; for adrenal insufficiency 80400 $29.75 This panel must include the following: Cortisol (82533 x 2) ACTH stimulation panel; for 21 hydroxylase deficiency This panel must include the following: 80402 $79.32 Cortisol (82533 x 2) 17 hydroxyprogesterone (83498 x 2) ACTH stimulation panel; for 3 beta- hydroxydehydrogenase deficiency This panel must 80406 $71.39 include the following: Cortisol (82533 x 2) 17 hydroxypregnenolone (84143 x 2) Aldosterone suppression evaluation panel (e.g., saline 80408 $114.48 infusion) This panel must include the following: Aldosterone (82088 x 2) Renin (84244 x 2) Calcitonin stimulation panel (e.g., calcium, 80410 $24.44 pentagastrin) This panel must include the following: Calcitonin (82308 x 3) Corticotropic releasing hormone (CRH) stimulation panel This panel must include the following: Cortisol 80412 $592.28 (82533 x 6) Adrenocorticotropic hormone (ACTH) (82024 x 6) Chorionic gonadotropin stimulation panel; testosterone 80414 $47.10 response This panel must include the following: Testosterone (84403 x 2 on 3 pooled blood samples) Chorionic gonadotropin stimulation panel; estradiol 80415 $50.97 response This panel must include the following: Estradiol (82670 x 2 on 3 pooled blood samples) Renal vein renin stimulation panel (e.g., captopril) This 80416 $154.66 panel must include the following: Renin (84244 x 6) Peripheral vein renin stimulation panel (e.g., captopril) 80417 $40.13 This panel must include the following: Renin (84244 x 2)

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101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Combined rapid anterior pituitary evaluation panel This panel must include the following: Adrenocorticotropic hormone (ACTH) (82024 x 4) Luteinizing hormone (LH) (83002 x 4) Follicle 80418 $528.60 stimulating hormone (FSH) (83001 x 4) Prolactin (84146 x 4) Human growth hormone (HGH) (83003 x 4) Cortisol (82533 x 4) Thyroid stimulating hormone (TSH) (84443 x 4) Dexamethasone suppression panel, 48 hour This panel must include the following: Free cortisol, urine (82530 80420 $119.61 x 2) Cortisol (82533 x 2) Volume measurement for timed collection (81050 x 2) Glucagon tolerance panel; for insulinoma This panel 80422 $42.03 must include the following: Glucose (82947 x 3) Insulin (83525 x 3) Glucagon tolerance panel; for pheochromocytoma This 80424 $46.06 panel must include the following: Catecholamines, fractionated (82384 x 2) Gonadotropin releasing hormone stimulation panel This panel must include the following: Follicle 80426 $135.37 stimulating hormone (FSH) (83001 x 4) Luteinizing hormone (LH) (83002 x 4) Growth hormone stimulation panel (e.g., arginine infusion, l-dopa administration) This panel must 80428 $60.84 include the following: Human growth hormone (HGH) (83003 x 4) Growth hormone suppression panel (glucose administration) This panel must include the following: 80430 $95.56 Glucose (82947 x 3) Human growth hormone (HGH) (83003 x 4) Insulin-induced C-peptide suppression panel This 80432 $123.23 panel must include the following: Insulin (83525) C- peptide (84681 x 5) Glucose (82947 x 5) Insulin tolerance panel; for ACTH insufficiency This 80434 $210.60 panel must include the following: Cortisol (82533 x 5) Glucose (82947 x 5) Insulin tolerance panel; for growth hormone deficiency 80435 $93.97 This panel must include the following: Glucose (82947 x 5) Human growth hormone (HGH) (83003 x 5) Metyrapone panel. This panel must include the 80436 $83.16 following: Cortisol (82533 x 2) 11 deoxycortisol (82634 x 2)

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101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Thyrotropin releasing hormone (TRH) stimulation 80438 $45.99 panel; 1 hour This panel must include the following: Thyroid stimulating hormone (TSH) (84443 x 3) Thyrotropin releasing hormone (TRH) stimulation 80439 $61.31 panel; 2 hour This panel must include the following: Thyroid stimulating hormone (TSH) (84443 x 4) Urinalysis Urinalysis, by dipstick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, 81000 $2.97 protein, specific gravity, urobilinogen, any number of these constituents; non-automated, with microscopy Urinalysis, by dipstick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, 81001 $2.90 protein, specific gravity, urobilinogen, any number of these constituents; automated, with microscopy Urinalysis, by dipstick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, 81002 $2.57 protein, specific gravity, urobilinogen, any number of these constituents; non-automated, without microscopy Urinalysis, by dipstick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, 81003 $2.05 protein, specific gravity, urobilinogen, any number of these constituents; automated, without microscopy Urinalysis; qualitative or semiquantitative, except 81005 $1.97 immunoassays Urinalysis; bacteriuria screen, except by culture or 81007 $22.15 dipstick 81015 $2.78 Urinalysis; microscopic only 81020 $3.47 Urinalysis; 2 or 3 glass test Urine pregnancy test, by visual color comparison 81025 $6.36 methods 81050 $2.74 Volume measurement for timed collection, each 81099 I.C. Unlisted urinalysis procedure Chemistry Ketone body(s) (e.g., acetone, acetoacetic acid, beta- 82009 $4.12 hydroxybutyrate); qualitative Ketone body(s) (e.g., acetone, acetoacetic acid, beta- 82010 $7.46 hydroxybutyrate); quantitative 82013 $10.19 Acetylcholinesterase 82016 $12.66 Acylcarnitines; qualitative, each specimen 82017 $15.39 Acylcarnitines; quantitative, each specimen 82024 $35.23 Adrenocorticotropic hormone (ACTH)

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Code Rate Description 82030 $23.53 Adenosine, 5-monophosphate, cyclic (cyclic AMP) 82040 $4.51 Albumin; serum, plasma or whole blood 82042 $5.75 Albumin; other source, quantitative, each specimen 82043 $5.28 Albumin; urine (e.g., microalbumin), quantitative Albumin; urine (e.g., microalbumin), semiquantitative 82044 $4.60 (e.g., reagent strip assay) 82045 $30.96 Albumin; ischemia modified 82075 $22.17 Alcohol (ethanol), breath 82085 $8.86 Aldolase 82088 $37.17 Aldosterone 82103 $12.26 Alpha-1-antitrypsin; total 82104 $13.20 Alpha-1-antitrypsin; phenotype 82105 $15.30 Alpha-fetoprotein (AFP); serum 82106 $15.30 Alpha-fetoprotein (AFP); amniotic fluid Alpha-fetoprotein (AFP); AFP-L3 fraction isoform and 82107 $58.75 total AFP (including ratio) 82108 $23.24 Aluminum 82120 $4.43 Amines, vaginal fluid, qualitative 82127 $12.66 Amino acids; single, qualitative, each specimen 82128 $12.66 Amino acids; multiple, qualitative, each specimen 82131 $16.98 Amino acids; single, quantitative, each specimen 82135 $15.01 Aminolevulinic acid, delta (ALA) Amino acids, 2 to 5 amino acids, quantitative, each 82136 $15.39 specimen Amino acids, 6 or more amino acids, quantitative, each 82139 $15.39 specimen 82140 $13.29 Ammonia 82143 $6.91 Amniotic fluid scan (spectrophotometric) 82150 $5.91 Amylase 82154 $26.30 Androstanediol glucuronide 82157 $26.70 Androstenedione 82160 $22.81 Androsterone 82163 $18.72 Angiotensin II 82164 $13.32 Angiotensin I – converting enzyme (ACE) 82172 $15.58 Apolipoprotein, each 82175 $17.30 Arsenic 82180 $9.01 Ascorbic acid (Vitamin C), blood 82190 $13.60 Atomic absorption spectroscopy, each analyte

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101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description 82232 $14.76 Beta-2 microglobulin 82239 $15.62 Bile acids; total 82240 $24.24 Bile acids; cholylglycine 82247 $4.57 Bilirubin; total 82248 $4.57 Bilirubin; direct 82252 $4.16 Bilirubin; feces, qualitative 82261 $15.39 Biotinidase, each specimen Blood, occult, by peroxidase activity (e.g., guaiac), qualitative, feces, consecutive collected specimens 82270 $3.24 with single determination, for colorectal neoplasm screening (i.e., patient was provided 3 cards or single triple card for consecutive collection) Blood, occult, by peroxidase activity (e.g., guaiac), 82271 $3.93 qualitative; other sources Blood, occult, by peroxidase activity (e.g., guaiac), 82272 $3.13 qualitative, feces, 1-3 simultaneous determinations, performed for other than colorectal neoplasm screening Blood, occult, by fecal hemoglobin determination by 82274 $14.51 immunoassay, qualitative, feces, 1-3 simultaneous determinations 82286 $4.71 Bradykinin 82300 $21.12 Cadmium Vitamin D; 25 hydroxy, includes fraction(s), if 82306 $27.01 performed 82308 $24.44 Calcitonin 82310 $4.71 Calcium; total 82330 $12.47 Calcium; ionized 82331 $9.86 Calcium; after calcium infusion test 82340 $5.50 Calcium; urine quantitative, timed specimen 82355 $10.56 Calculus; qualitative analysis 82360 $11.74 Calculus; quantitative analysis, chemical 82365 $11.76 Calculus; infrared spectroscopy 82370 $11.42 Calculus; X-ray diffraction 82373 $16.47 Carbohydrate deficient transferrin 82374 $4.46 Carbon dioxide (bicarbonate) 82375 $11.24 Carboxyhemoglobin; quantitative 82376 $10.40 Carboxyhemoglobin; qualitative 82378 $17.30 Carcinoembryonic antigen (CEA) 82379 $15.39 Carnitine (total and free), quantitative, each specimen

14

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description 82380 $8.42 Carotene 82382 $20.17 Catecholamines; total urine 82383 $22.85 Catecholamines; blood 82384 $23.04 Catecholamines; fractionated 82387 $16.47 Cathepsin-D 82390 $9.80 Ceruloplasmin 82397 $12.88 Chemiluminescent assay 82415 $11.56 Chloramphenicol 82435 $4.20 Chloride; blood 82436 $4.59 Chloride; urine 82438 $4.46 Chloride; other source 82441 $5.48 Chlorinated hydrocarbons, screen 82465 $3.97 Cholesterol, serum or whole blood, total 82480 $7.18 Cholinesterase; serum 82482 $7.25 Cholinesterase; RBC 82485 $18.84 Chondroitin B sulfate, quantitative 82495 $18.50 Chromium 82507 $25.37 Citrate 82523 $17.05 Collagen cross links, any method 82525 $11.32 Copper 82528 $20.54 Corticosterone 82530 $15.24 Cortisol; free 82533 $14.87 Cortisol; total 82540 $4.23 Creatine Column chromatography, includes mass spectrometry, if performed (e.g., HPLC, LC, LC/MS, LC/MS-MS, 82542 $17.80 GC, GC/MS-MS, GC/MS, HPLC/MS), non-drug analyte(s) not elsewhere specified, qualitative or quantitative, each specimen 82550 $5.94 Creatine kinase (CK), (CPK); total 82552 $12.21 Creatine kinase (CK), (CPK); isoenzymes 82553 $10.54 Creatine kinase (CK), (CPK); MB fraction only 82554 $10.82 Creatine kinase (CK), (CPK); isoforms 82565 $4.68 Creatinine; blood 82570 $4.72 Creatinine; other source 82575 $8.62 Creatinine; clearance 82585 $10.45 Cryofibrinogen

15

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Cryoglobulin, qualitative or semi-quantitative (e.g., 82595 $5.90 cryocrit) 82600 $17.70 Cyanide 82607 $13.75 Cyanocobalamin (Vitamin B-12); Cyanocobalamin (Vitamin B-12); unsaturated binding 82608 $13.06 capacity 82610 $13.68 Cystatin C 82615 $7.45 Cystine and homocystine, urine, qualitative 82626 $23.05 Dehydroepiandrosterone (DHEA) 82627 $20.28 Dehydroepiandrosterone-sulfate (DHEA-S) 82633 $28.26 Desoxycorticosterone, 11- 82634 $26.70 Deoxycortisol, 11- 82638 $11.17 Dibucaine number 82642 $24.29 Dihydrotestosterone (DHT) Vitamin D; 1, 25 dihydroxy, includes fraction(s), if 82652 $35.12 performed Elastase, pancreatic (EL-1), fecal, qualitative or semi- 82656 $10.52 quantitative Enzyme activity in blood cells, cultured cells, or tissue, 82657 $16.47 not elsewhere specified; nonradioactive substrate, each specimen Enzyme activity in blood cells, cultured cells, or tissue, 82658 $32.53 not elsewhere specified; radioactive substrate, each specimen 82664 $45.44 Electrophoretic technique, not elsewhere specified 82668 $17.14 Erythropoietin 82670 $25.48 Estradiol 82671 $29.47 Estrogens; fractionated 82672 $19.79 Estrogens; total 82677 $22.05 Estriol 82679 $22.76 Estrone 82693 $13.59 Ethylene glycol 82696 $21.52 Etiocholanolone 82705 $4.65 Fat or lipids, feces; qualitative 82710 $15.33 Fat or lipids, feces; quantitative 82715 $16.97 Fat differential, feces, quantitative 82725 $13.87 Fatty acids, nonesterified 82726 $16.47 Very long chain fatty acids 82728 $12.43 Ferritin

16

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Fetal fibronectin, cervicovaginal secretions, semi- 82731 $58.75 quantitative 82735 $16.91 Fluoride 82746 $13.41 Folic acid; serum 82747 $15.80 Folic acid; RBC 82757 $15.81 Fructose, semen 82759 $19.59 Galactokinase, RBC 82760 $10.21 Galactose 82775 $19.22 Galactose-1-phosphate uridyl transferase; quantitative 82776 $8.67 Galactose-1-phosphate uridyl transferase; screen 82777 $32.69 Galectin-3 Gammaglobulin (immunoglobulin); IgA, IgD, IgG, 82784 $8.48 IgM, each 82785 $15.01 Gammaglobulin (immunoglobulin); IgE Gammaglobulin (immunoglobulin); immunoglobulin 82787 $7.31 subclasses (e.g., IgG1, 2, 3, or 4), each 82800 $8.13 Gases, blood, pH only Gases, blood, any combination of pH, pCO2, pO2, 82803 $19.26 CO2, HCO3 (including calculated O2 saturation) Gases, blood, any combination of pH, pCO2, pO2, CO2, HCO3 (including calculated O2 saturation); with 82805 $58.20 O2 saturation, by direct measurement, except pulse oximetry Gases, blood, O2 saturation only, by direct 82810 $7.96 measurement, except pulse oximetry Hemoglobin-oxygen affinity (pO2 for 50% 82820 $9.86 hemoglobin saturation with oxygen) Gastric acid analysis, includes pH if performed, each 82930 $4.97 specimen 82938 $16.14 Gastrin after secretin stimulation 82941 $16.08 Gastrin 82943 $13.03 Glucagon 82945 $3.58 Glucose, body fluid, other than blood 82946 $13.75 Glucagon tolerance test 82947 $3.58 Glucose; quantitative, blood (except reagent strip) 82948 $3.72 Glucose; blood, reagent strip 82950 $4.33 Glucose; post glucose dose (includes glucose) Glucose; tolerance test (GTT), 3 specimens (includes 82951 $11.74 glucose)

17

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Glucose; tolerance test, each additional beyond 3 82952 $3.58 specimens (List separately in addition to code for primary procedure) Glucose-6-phosphate dehydrogenase (G6PD); 82955 $8.84 quantitative 82960 $5.52 Glucose-6-phosphate dehydrogenase (G6PD); screen Glucose, blood by glucose monitoring device(s) 82962 $2.42 cleared by the FDA specifically for home use 82963 $19.59 Glucosidase, beta 82965 $9.72 Glutamate dehydrogenase 82977 $6.57 Glutamyltransferase, gamma (GGT) 82978 $13.00 Glutathione 82979 $8.62 Glutathione reductase, RBC 82985 $13.75 Glycated protein 83001 $16.95 Gonadotropin; follicle stimulating hormone (FSH) 83002 $16.89 Gonadotropin; luteinizing hormone (LH) 83003 $15.21 Growth hormone, human (HGH) (somatotropin) Growth stimulation expressed 2 (ST2, Interleukin 83006 $55.86 1 receptor like-1) Helicobacter pylori, blood test analysis for urease 83009 $61.44 activity, non-radioactive isotope (e.g., C-13) 83010 $11.47 Haptoglobin; quantitative 83012 $19.87 Haptoglobin; phenotypes Helicobacter pylori; breath test analysis for urease 83013 $61.44 activity, non-radioactive isotope (e.g., C-13) 83014 $7.17 Helicobacter pylori; drug administration Heavy metal (e.g., arsenic, barium, beryllium, bismuth, 83015 $17.18 antimony, mercury); qualitative, any number of analytes Heavy metal (e.g., arsenic, barium, beryllium, bismuth, 83018 $20.04 antimony, mercury); quantitative, each, not elsewhere specified Hemoglobin fractionation and quantitation; 83020 $11.74 electrophoresis (e.g., A2, S, C, and/or F) Hemoglobin fractionation and quantitation; 83021 $16.47 chromatography (e.g., A2, S, C, and/or F) 83026 $2.96 Hemoglobin; by copper sulfate method, non-automated 83030 $7.94 Hemoglobin; F (fetal), chemical 83033 $5.91 Hemoglobin; F (fetal), qualitative 83036 $8.86 Hemoglobin; glycosylated (A1C)

18

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Hemoglobin; glycosylated (A1C) by device cleared by 83037 $8.86 FDA for home use 83045 $4.80 Hemoglobin; methemoglobin, qualitative 83050 $6.69 Hemoglobin; methemoglobin, quantitative 83051 $6.67 Hemoglobin; plasma 83060 $7.54 Hemoglobin; sulfhemoglobin, quantitative 83065 $6.65 Hemoglobin; thermolabile 83068 $7.72 Hemoglobin; unstable, screen 83069 $3.61 Hemoglobin; urine 83070 $4.33 Hemosiderin, qualitative 83080 $15.39 b-Hexosaminidase, each assay 83088 $26.94 Histamine 83090 $15.39 Homocysteine 83150 $17.65 Homovanillic acid (HVA) 83491 $15.99 Hydroxycorticosteroids, 17- (17-OHCS) 83497 $11.76 Hydroxyindolacetic acid, 5-(HIAA) 83498 $24.78 Hydroxyprogesterone, 17-d 83500 $20.66 Hydroxyproline; free 83505 $22.17 Hydroxyproline; total Immunoassay for analyte other than infectious agent 83516 $10.52 antibody or infectious agent antigen; qualitative or semiquantitative, multiple step method Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or 83518 $7.74 semiquantitative, single step method (e.g., reagent strip) Immunoassay for analyte other than infectious agent 83519 $13.59 antibody or infectious agent antigen; quantitative, by radioimmunoassay (e.g., RIA) Immunoassay for analyte other than infectious agent 83520 $12.76 antibody or infectious agent antigen; quantitative, not otherwise specified 83525 $10.43 Insulin; total 83527 $11.81 Insulin; free 83528 $14.64 Intrinsic factor 83540 $5.90 Iron 83550 $7.97 Iron binding capacity 83570 $8.08 Isocitric dehydrogenase (IDH) 83582 $12.93 Ketogenic steroids, fractionation

19

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description 83586 $11.67 Ketosteroids, 17- (17-KS); total 83593 $23.99 Ketosteroids, 17- (17-KS); fractionation 83605 $9.75 Lactate (lactic acid) 83615 $5.50 Lactate dehydrogenase (LD), (LDH); Lactate dehydrogenase (LD), (LDH); isoenzymes, 83625 $11.67 separation and quantitation 83630 $17.91 Lactoferrin, fecal; qualitative 83631 $17.91 Lactoferrin, fecal; quantitative Lactogen, human placental (HPL) human chorionic 83632 $18.45 somatomammotropin 83633 $8.31 Lactose, urine, qualitative 83655 $11.05 Lead Fetal lung maturity assessment; lecithin sphingomyelin 83661 $20.05 (L/S) ratio 83662 $17.25 Fetal lung maturity assessment; foam stability test Fetal lung maturity assessment; fluorescence 83663 $17.25 polarization 83664 $17.25 Fetal lung maturity assessment; lamellar body density 83670 $8.36 Leucine aminopeptidase (LAP) 83690 $6.29 Lipase 83695 $11.81 Lipoprotein (a) 83698 $34.22 Lipoprotein-associated phospholipase A2 (Lp-PLA2) Lipoprotein, blood; electrophoretic separation and 83700 $10.27 quantitation Lipoprotein, blood; high resolution fractionation and quantitation of lipoproteins including lipoprotein 83701 $25.02 subclasses when performed (e.g., electrophoresis, ultracentrifugation) Lipoprotein, blood; quantitation of lipoprotein particle number(s) (e.g., by nuclear magnetic resonance 83704 $28.78 spectroscopy), includes lipoprotein particle subclass(es), when performed Lipoprotein, direct measurement; high density 83718 $7.48 cholesterol (HDL cholesterol) 83719 $10.61 Lipoprotein, direct measurement; VLDL cholesterol 83721 $8.70 Lipoprotein, direct measurement; LDL cholesterol Lipoprotein, direct measurement; small dense LDL 83722 $26.18 cholesterol 83727 $15.68 Luteinizing releasing factor (LRH) 83735 $6.11 Magnesium

20

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description 83775 $6.72 Malate dehydrogenase 83785 $22.44 Manganese Mass spectrometry and tandem mass spectrometry (e.g., MS, MS/MS, MALDI, MS-TOF, QTOF), non- 83789 $17.81 drug analyte(s) not elsewhere specified, qualitative or quantitative, each specimen 83825 $14.83 Mercury, quantitative 83835 $15.46 Metanephrines 83857 $9.80 Methemalbumin Microfluidic analysis utilizing an integrated collection 83861 $16.61 and analysis device, tear osmolarity 83864 $21.06 Mucopolysaccharides, acid, quantitative 83872 $5.35 Mucin, synovial fluid (Ropes test) 83873 $15.69 Myelin basic protein, cerebrospinal fluid 83874 $11.78 Myoglobin 83876 $37.58 Myeloperoxidase (MPO) 83880 $30.96 Natriuretic peptide 83883 $12.41 Nephelometry, each analyte not elsewhere specified 83885 $22.36 Nickel 83915 $10.17 Nucleotidase 5’- 83916 $20.24 Oligoclonal immune (oligoclonal bands) 83918 $17.44 Organic acids; total, quantitative, each specimen 83919 $15.01 Organic acids; qualitative, each specimen 83921 $15.67 Organic acid, single, quantitative 83930 $6.03 Osmolality; blood 83935 $6.22 Osmolality; urine 83937 $27.23 Osteocalcin (bone g1a protein) 83945 $11.74 Oxalate 83950 $58.75 Oncoprotein; HER-2/neu 83951 $58.75 Oncoprotein; des-gamma-carboxy-prothrombin (DCP) 83970 $37.65 Parathormone (parathyroid hormone) 83986 $3.27 pH; body fluid, not otherwise specified 83987 $3.27 pH; exhaled breath condensate 83992 $15.16 Phencyclidine (PCP) 83993 $17.91 Calprotectin, fecal 84030 $5.02 Phenylalanine (PKU), blood 84035 $3.34 Phenylketones, qualitative

21

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description 84060 $6.74 Phosphatase, acid; total 84066 $8.81 Phosphatase, acid; prostatic 84075 $4.72 Phosphatase, alkaline; 84078 $6.66 Phosphatase, alkaline; heat stable (total not included) 84080 $13.48 Phosphatase, alkaline; isoenzymes 84081 $15.07 Phosphatidylglycerol 84085 $8.62 Phosphogluconate, 6-, dehydrogenase, RBC 84087 $9.41 Phosphohexose isomerase 84100 $4.32 Phosphorus inorganic (phosphate); 84105 $4.72 Phosphorus inorganic (phosphate); urine 84106 $4.30 Porphobilinogen, urine; qualitative 84110 $7.70 Porphobilinogen, urine; quantitative Evaluation of cervicovaginal fluid for specific amniotic fluid protein(s) (e.g., placental alpha macroglobulin-1 84112 $72.49 [PAMG-1], placental protein 12 [PP12], alpha- fetoprotein), qualitative, each specimen 84119 $9.87 Porphyrins, urine; qualitative 84120 $13.42 Porphyrins, urine; quantitation and fractionation 84126 $28.90 Porphyrins, feces, quantitative 84132 $4.20 Potassium; serum, plasma or whole blood 84133 $3.93 Potassium; urine 84134 $13.31 Prealbumin 84135 $17.46 Pregnanediol 84138 $17.27 Pregnanetriol 84140 $18.86 Pregnenolone 84143 $20.81 17-hydroxypregnenolone 84144 $19.03 Progesterone 84145 $24.44 Procalcitonin (PCT) 84146 $17.67 Prolactin 84150 $30.86 Prostaglandin, each Prostate specific antigen (PSA); complexed (direct 84152 $16.78 measurement) 84153 $16.78 Prostate specific antigen (PSA); total 84154 $16.78 Prostate specific antigen (PSA); free Protein, total, except by refractometry; serum, plasma 84155 $3.35 or whole blood 84156 $3.35 Protein, total, except by refractometry; urine

22

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Protein, total, except by refractometry; other source 84157 $3.35 (e.g., synovial fluid, cerebrospinal fluid) 84160 $4.72 Protein, total, by refractometry, any source 84163 $13.74 Pregnancy-associated plasma protein-A (PAPP-A) Protein; electrophoretic fractionation and quantitation, 84165 $9.80 serum Protein; electrophoretic fractionation and quantitation, 84166 $16.26 other fluids with concentration (e.g., urine, CSF) Protein; Western Blot, with interpretation and report, 84181 $15.53 blood or other body fluid Protein; Western Blot, with interpretation and report, 84182 $21.58 blood or other body fluid, immunological probe for band identification, each 84202 $13.09 Protoporphyrin, RBC; quantitative 84203 $7.85 Protoporphyrin, RBC; screen 84206 $19.72 Proinsulin 84207 $25.63 Pyridoxal phosphate (Vitamin B-6) 84210 $10.70 Pyruvate 84220 $8.62 Pyruvate kinase 84228 $10.61 Quinine 84233 $64.93 Receptor assay; estrogen 84234 $59.18 Receptor assay; progesterone Receptor assay; endocrine, other than estrogen or 84235 $52.63 progesterone (specify hormone) 84238 $33.35 Receptor assay; non-endocrine (specify receptor) 84244 $20.06 Renin 84252 $18.46 Riboflavin (Vitamin B-2) 84255 $23.29 Selenium 84260 $28.26 Serotonin 84270 $19.82 Sex hormone binding globulin (SHBG) 84275 $12.26 Sialic acid 84285 $21.47 Silica 84295 $4.39 Sodium; serum, plasma or whole blood 84300 $4.43 Sodium; urine 84302 $4.43 Sodium; other source 84305 $19.40 Somatomedin 84307 $16.67 Somatostatin 84311 $6.38 Spectrophotometry, analyte not elsewhere specified

23

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description 84315 $2.42 Specific gravity (except urine) Sugars, chromatographic, TLC or paper 84375 $28.82 chromatography Sugars (mono-, di-, and oligosaccharides); single 84376 $5.02 qualitative, each specimen Sugars (mono-, di-, and oligosaccharides); multiple 84377 $5.02 qualitative, each specimen Sugars (mono-, di-, and oligosaccharides); single 84378 $10.51 quantitative, each specimen Sugars (mono-, di-, and oligosaccharides); multiple 84379 $10.51 quantitative, each specimen 84392 $4.33 Sulfate, urine 84402 $23.24 Testosterone; free 84403 $23.55 Testosterone; total Testosterone; bioavailable, direct measurement (e.g., 84410 $46.78 differential precipitation) 84425 $19.37 Thiamine (Vitamin B-1) 84430 $10.61 Thiocyanate Thromboxane metabolite(s), including thromboxane if 84431 $25.94 performed, urine 84432 $14.65 Thyroglobulin 84436 $6.27 Thyroxine; total 84437 $5.90 Thyroxine; requiring elution (e.g., neonatal) 84439 $8.22 Thyroxine; free 84442 $13.48 Thyroxine binding globulin (TBG) 84443 $15.33 Thyroid stimulating hormone (TSH) 84445 $46.39 Thyroid stimulating immune globulins (TSI) 84446 $12.94 Tocopherol alpha (Vitamin E) 84449 $16.42 Transcortin (cortisol binding globulin) 84450 $4.72 Transferase; aspartate amino (AST) (SGOT) 84460 $4.83 Transferase; alanine amino (ALT) (SGPT) 84466 $11.64 Transferrin 84478 $5.24 Triglycerides Thyroid hormone (T3 or T4) uptake or thyroid 84479 $5.90 hormone binding ratio (THBR) 84480 $12.94 Triiodothyronine T3; total (TT-3) 84481 $15.46 Triiodothyronine T3; free 84482 $14.38 Triiodothyronine T3; reverse 84484 $9.21 Troponin, quantitative

24

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description 84485 $6.57 Trypsin; duodenal fluid 84488 $6.66 Trypsin; feces, qualitative 84490 $7.34 Trypsin; feces, quantitative, 24-hour collection 84510 $9.49 Tyrosine 84512 $7.46 Troponin, qualitative 84520 $3.61 Urea nitrogen; quantitative 84525 $3.79 Urea nitrogen; semiquantitative (e.g., reagent strip test) 84540 $4.33 Urea nitrogen, urine 84545 $6.03 Urea nitrogen, clearance 84550 $4.12 Uric acid; blood 84560 $4.33 Uric acid; other source 84577 $15.33 Urobilinogen, feces, quantitative 84578 $3.30 Urobilinogen, urine; qualitative 84580 $7.45 Urobilinogen, urine; quantitative, timed specimen 84583 $4.59 Urobilinogen, urine; semiquantitative 84585 $14.13 Vanillylmandelic acid (VMA), urine 84586 $32.23 Vasoactive intestinal peptide (VIP) 84588 $30.96 Vasopressin (antidiuretic hormone, ADH) 84590 $10.59 Vitamin A 84591 $12.60 Vitamin, not otherwise specified 84597 $12.52 Vitamin K 84600 $14.67 Volatiles (e.g., acetic anhydride, diethylether) 84620 $10.81 Xylose absorption test, blood and/or urine 84630 $10.39 Zinc 84681 $18.99 C-peptide 84702 $13.74 Gonadotropin, chorionic (hCG); quantitative 84703 $6.86 Gonadotropin, chorionic (hCG); qualitative 84704 $13.74 Gonadotropin, chorionic (hCG); free beta chain Ovulation tests, by visual color comparison methods 84830 $9.38 for human luteinizing hormone 84999 $4.28 Unlisted chemistry procedure Hematology and Coagulation 85002 $4.12 Bleeding time 85004 $5.90 Blood count; automated differential WBC count Blood count; blood smear, microscopic examination 85007 $3.13 with manual differential WBC count

25

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Blood count; blood smear, microscopic examination 85008 $3.13 without manual differential WBC count Blood count; manual differential WBC count, buffy 85009 $3.75 coat 85013 $5.17 Blood count; spun microhematocrit 85014 $2.16 Blood count; hematocrit (Hct) 85018 $2.16 Blood count; hemoglobin (Hgb) Blood count; complete (CBC), automated (Hgb, Hct, 85025 $7.09 RBC, WBC and platelet count) and automated differential WBC count Blood count; complete (CBC), automated (Hgb, Hct, 85027 $5.90 RBC, WBC and platelet count) Blood count; manual cell count (erythrocyte, 85032 $3.93 leukocyte, or platelet) each 85041 $2.76 Blood count; red blood cell (RBC), automated 85044 $3.93 Blood count; reticulocyte, manual 85045 $3.64 Blood count; reticulocyte, automated Blood count; reticulocytes, automated, including 1 or more cellular parameters (e.g., reticulocyte hemoglobin 85046 $5.08 content [CHr], immature reticulocyte fraction [IRF], reticulocyte volume [MRV], RNA content), direct measurement 85048 $2.31 Blood count; leukocyte (WBC), automated 85049 $4.09 Blood count; platelet, automated 85055 $26.41 Reticulated platelet assay 85130 $10.85 Chromogenic substrate assay 85170 $12.04 Clot retraction 85175 $15.05 Clot lysis time, whole blood dilution 85210 $11.84 Clotting; factor II, prothrombin, specific 85220 $16.10 Clotting; factor V (AcG or proaccelerin), labile factor 85230 $16.33 Clotting; factor VII (proconvertin, stable factor) 85240 $16.33 Clotting; factor VIII (AHG), 1-stage 85244 $18.63 Clotting; factor VIII related antigen 85245 $20.92 Clotting; factor VIII, VW factor, ristocetin cofactor 85246 $20.92 Clotting; factor VIII, VW factor antigen Clotting; factor VIII, von Willebrand factor, 85247 $20.92 multimetric analysis 85250 $17.37 Clotting; factor IX (PTC or Christmas) 85260 $16.33 Clotting; factor X (Stuart-Prower)

26

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description 85270 $16.33 Clotting; factor XI (PTA) 85280 $17.65 Clotting; factor XII (Hageman) 85290 $14.90 Clotting; factor XIII (fibrin stabilizing) Clotting; factor XIII (fibrin stabilizing), screen 85291 $8.11 solubility 85292 $17.27 Clotting; prekallikrein assay (Fletcher factor assay) Clotting; high molecular weight kininogen assay 85293 $17.27 (Fitzgerald factor assay) Clotting inhibitors or anticoagulants; antithrombin III, 85300 $10.81 activity Clotting inhibitors or anticoagulants; antithrombin III, 85301 $9.86 antigen assay 85302 $10.96 Clotting inhibitors or anticoagulants; protein C, antigen 85303 $12.62 Clotting inhibitors or anticoagulants; protein C, activity 85305 $10.59 Clotting inhibitors or anticoagulants; protein S, total 85306 $13.98 Clotting inhibitors or anticoagulants; protein S, free 85307 $13.98 Activated Protein C (APC) resistance assay 85335 $11.74 Factor inhibitor test 85337 $12.76 Thrombomodulin 85345 $3.93 Coagulation time; Lee and White 85347 $3.89 Coagulation time; activated 85348 $3.40 Coagulation time; other methods 85360 $7.67 Euglobulin lysis Fibrin(ogen) degradation (split) products (FDP) (FSP); 85362 $6.29 agglutination slide, semiquantitative Fibrin(ogen) degradation (split) products (FDP) (FSP); 85366 $59.45 paracoagulation Fibrin(ogen) degradation (split) products (FDP) (FSP); 85370 $10.36 quantitative Fibrin degradation products, D-dimer; qualitative or 85378 $7.18 semiquantitative 85379 $9.28 Fibrin degradation products, D-dimer; quantitative Fibrin degradation products, D-dimer; ultrasensitive 85380 $9.28 (e.g., for evaluation for venous thromboembolism), qualitative or semiquantitative 85384 $7.75 Fibrinogen; activity 85385 $10.68 Fibrinogen; antigen Fibrinolysins or coagulopathy screen, interpretation 85390 $11.44 and report

27

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Coagulation and fibrinolysis, functional activity, not 85397 $22.80 otherwise specified (e.g., ADAMTS-13), each analyte 85400 $7.03 Fibrinolytic factors and inhibitors; plasmin 85410 $7.03 Fibrinolytic factors and inhibitors; alpha-2 antiplasmin Fibrinolytic factors and inhibitors; plasminogen 85415 $15.68 activator Fibrinolytic factors and inhibitors; plasminogen, except 85420 $5.96 antigenic assay Fibrinolytic factors and inhibitors; plasminogen, 85421 $9.29 antigenic assay 85441 $3.83 Heinz bodies; direct 85445 $6.22 Heinz bodies; induced, acetyl phenylhydrazine Hemoglobin or RBCs, fetal, for fetomaternal 85460 $7.06 hemorrhage; differential lysis (Kleihauer-Betke) Hemoglobin or RBCs, fetal, for fetomaternal 85461 $6.92 hemorrhage; rosette 85475 $8.09 Hemolysin, acid 85520 $11.94 Heparin assay 85525 $10.80 Heparin neutralization 85530 $11.94 Heparin-protamine tolerance test 85536 $5.90 Iron stain, peripheral blood 85540 $7.85 Leukocyte alkaline phosphatase with count 85547 $7.85 Mechanical fragility, RBC 85549 $17.10 Muramidase 85555 $6.10 Osmotic fragility, RBC; unincubated 85557 $12.18 Osmotic fragility, RBC; incubated 85576 $19.59 Platelet, aggregation (in vitro), each agent 85597 $16.40 Phospholipid neutralization; platelet 85598 $16.40 Phospholipid neutralization; hexagonal phospholipid 85610 $3.58 Prothrombin time 85611 $3.60 Prothrombin time; substitution, plasma fractions, each 85612 $12.92 Russell viper venom time (includes venom); undiluted 85613 $8.74 Russell viper venom time (includes venom); diluted 85635 $8.98 Reptilase test 85651 $3.24 Sedimentation rate, erythrocyte; non-automated 85652 $2.46 Sedimentation rate, erythrocyte; automated 85660 $5.02 Sickling of RBC, reduction 85670 $5.26 Thrombin time; plasma

28

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description 85675 $6.24 Thrombin time; titer 85705 $8.79 Thromboplastin inhibition, tissue Thromboplastin time, partial (PTT); plasma or whole 85730 $5.48 blood Thromboplastin time, partial (PTT); substitution, 85732 $5.90 plasma fractions, each 85810 $10.65 Viscosity 85999 I.C. Unlisted hematology and coagulation procedure Immunology Agglutinins, febrile (e.g., Brucella, Francisella, Murine 86000 $6.37 typhus, Q fever, Rocky Mountain spotted fever, scrub typhus), each antigen Allergen specific IgG; quantitative or semiquantitative, 86001 $5.78 each allergen Allergen specific IgE; quantitative or semiquantitative, 86003 $4.76 crude allergen extract, each Allergen specific IgE; qualitative, multiallergen screen 86005 $7.27 (e.g., disk, sponge, card) Allergen specific IgE; quantitative or semiquantitative, 86008 $16.36 recombinant or purified component, each 86021 $13.74 Antibody identification; leukocyte antibodies 86022 $16.76 Antibody identification; platelet antibodies Antibody identification; platelet associated 86023 $11.36 immunoglobulin assay 86038 $11.02 Antinuclear antibodies (ANA) 86039 $10.18 Antinuclear antibodies (ANA); titer 86060 $6.66 Antistreptolysin 0; titer 86063 $5.26 Antistreptolysin 0; screen 86140 $4.72 C-reactive protein 86141 $11.81 C-reactive protein; high sensitivity (hsCRP) 86146 $23.21 Beta 2 Glycoprotein I antibody, each 86147 $23.21 Cardiolipin (phospholipid) antibody, each Ig class 86148 $14.66 Anti-phosphatidylserine (phospholipid) antibody Cell enumeration using immunologic selection and 86152 $224.13 identification in fluid specimen (e.g., circulating tumor cells in blood); 86155 $14.59 Chemotaxis assay, specify method 86156 $6.11 Cold agglutinin; screen 86157 $7.35 Cold agglutinin; titer 86160 $10.94 Complement; antigen, each component

29

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description 86161 $10.94 Complement; functional activity, each component 86162 $18.54 Complement; total hemolytic (CH50) 86171 $9.13 Complement fixation tests, each antigen 86200 $11.81 Cyclic citrullinated peptide (CCP), antibody 86215 $12.08 Deoxyribonuclease, antibody Deoxyribonucleic acid (DNA) antibody; native or 86225 $12.54 double stranded Deoxyribonucleic acid (DNA) antibody; single 86226 $11.05 stranded Extractable nuclear antigen, antibody to, any method 86235 $16.36 (e.g., nRNP, SS-A, SS-B, Sm, RNP, Sc170, J01), each antibody Fluorescent noninfectious agent antibody; screen, each 86255 $10.99 antibody Fluorescent noninfectious agent antibody; titer, each 86256 $10.99 antibody 86277 $14.36 Growth hormone, human (HGH), antibody 86280 $7.48 Hemagglutination inhibition test (HAI) Immunoassay for tumor antigen, qualitative or 86294 $18.89 semiquantitative (e.g., bladder tumor antigen) Immunoassay for tumor antigen, quantitative; CA 15-3 86300 $18.99 (27.29) 86301 $18.99 Immunoassay for tumor antigen, quantitative; CA 19-9 86304 $18.99 Immunoassay for tumor antigen, quantitative; CA 125 86305 $18.99 Human epididymis protein 4 (HE4) 86308 $4.72 Heterophile antibodies; screening 86309 $5.90 Heterophile antibodies; titer Heterophile antibodies; titers after absorption with beef 86310 $6.72 cells and guinea pig kidney Immunoassay for tumor antigen, other antigen, 86316 $18.99 quantitative (e.g., CA 50, 72-4, 549), each Immunoassay for infectious agent antibody, 86317 $13.67 quantitative, not otherwise specified Immunoassay for infectious agent antibody, qualitative 86318 $13.37 or semiquantitative, single step method (e.g., reagent strip) 86320 $22.11 Immunoelectrophoresis; serum Immunoelectrophoresis; other fluids (e.g., urine, 86325 $20.40 cerebrospinal fluid) with concentration 86327 $22.11 Immunoelectrophoresis; crossed (2-dimensional assay)

30

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative, single step method 86328 $45.23 (e.g., reagent strip); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]). 86329 $12.81 Immunodiffusion; not elsewhere specified Immunodiffusion; gel diffusion, qualitative 86331 $10.93 (Ouchterlony), each antigen or antibody 86332 $22.23 Immune complex assay 86334 $20.39 Immunofixation electrophoresis; serum Immunofixation electrophoresis; other fluids with 86335 $26.77 concentration (e.g., urine, CSF) 86336 $14.22 Inhibin A 86337 $19.53 Insulin antibodies 86340 $13.75 Intrinsic factor antibodies 86341 $18.05 Islet cell antibody 86343 $11.36 Leukocyte histamine release test (LHR) 86344 $7.68 Leukocyte phagocytosis Cellular function assay involving stimulation (e.g., 86352 $123.93 mitogen or antigen) and detection of biomarker (e.g., ATP) Lymphocyte transformation, mitogen (phytomitogen) 86353 $44.72 or antigen induced blastogenesis 86355 $34.42 B cells, total count Mononuclear cell antigen, quantitative (e.g., flow 86356 $24.43 cytometry), not otherwise specified, each antigen 86357 $34.42 Natural killer (NK) cells, total count 86359 $34.42 T cells; total count 86360 $42.86 T cells; absolute CD4 and CD8 count, including ratio 86361 $24.43 T cells; absolute CD4 count 86367 $57.47 Stem cells (i.e., CD34), total count Microsomal antibodies (e.g., thyroid or liver-kidney), 86376 $13.27 each 86382 $15.43 Neutralization test, viral 86384 $10.39 Nitroblue tetrazolium dye test (NTD) 86386 $16.09 Nuclear Matrix Protein 22 (NMP22), qualitative 86403 $9.29 Particle agglutination; screen, each antibody 86406 $9.70 Particle agglutination; titer, each antibody

31

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description 86408 I.C. Neutralizing antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]); screen 86409 I.C. Neutralizing antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]); titer 86413 I.C. Severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) (Coronavirus disease [COVID-19]) antibody, quantitative 86430 $5.17 Rheumatoid factor; qualitative 86431 $5.17 Rheumatoid factor; quantitative Tuberculosis test, cell mediated immunity antigen 86480 $56.54 response measurement; gamma interferon Tuberculosis test, cell mediated immunity antigen 86481 $73.89 response measurement; enumeration of gamma interferon-producing T-cells in cell suspension 86485 $24.14 Skin test; candida 86590 $10.08 Streptokinase, antibody Syphilis test, non-treponemal antibody; qualitative 86592 $3.89 (e.g., VDRL, RPR, ART) 86593 $4.02 Syphilis test, non-treponemal antibody; quantitative 86602 $9.28 Antibody; actinomyces 86603 $11.74 Antibody; adenovirus 86606 $13.74 Antibody; Aspergillus 86609 $11.75 Antibody; bacterium, not elsewhere specified 86611 $9.28 Antibody; Bartonella 86612 $11.77 Antibody; Blastomyces 86615 $12.03 Antibody; Bordetella Antibody; Borrelia burgdorferi (Lyme disease) 86617 $14.13 confirmatory test (e.g., Western Blot or immunoblot) 86618 $15.53 Antibody; Borrelia burgdorferi (Lyme disease) 86619 $12.21 Antibody; Borrelia (relapsing fever) 86622 $8.15 Antibody; Brucella 86625 $11.97 Antibody; Campylobacter 86628 $10.95 Antibody; Candida 86631 $10.79 Antibody; Chlamydia 86632 $11.57 Antibody; Chlamydia, IgM 86635 $10.47 Antibody; Coccidioides 86638 $11.06 Antibody; Coxiella burnetii (Q fever)

32

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description 86641 $13.14 Antibody; Cryptococcus 86644 $13.13 Antibody; cytomegalovirus (CMV) 86645 $15.37 Antibody; cytomegalovirus (CMV), IgM 86648 $13.87 Antibody; Diphtheria 86651 $12.03 Antibody; encephalitis, California (La Crosse) 86652 $12.03 Antibody; encephalitis, Eastern equine 86653 $12.03 Antibody; encephalitis, St. Louis 86654 $12.03 Antibody; encephalitis, Western equine 86658 $11.88 Antibody; enterovirus (e.g., coxsackie, echo, polio) 86663 $11.97 Antibody; Epstein-Barr (EB) virus, early antigen (EA) Antibody; Epstein-Barr (EB) virus, nuclear antigen 86664 $13.95 (EBNA) 86665 $16.55 Antibody; Epstein-Barr (EB) virus, viral capsid (VCA) 86666 $9.28 Antibody; Ehrlichia 86668 $10.46 Antibody; Francisella tularensis 86671 $11.18 Antibody; fungus, not elsewhere specified 86674 $13.43 Antibody; Giardia lamblia 86677 $13.23 Antibody; Helicobacter pylori 86682 $11.87 Antibody; helminth, not elsewhere specified 86684 $14.45 Antibody; Haemophilus influenza 86687 $7.65 Antibody; HTLV-I 86688 $12.77 Antibody; HTLV-II Antibody; HTLV or HIV antibody, confirmatory test 86689 $17.66 (e.g., Western Blot) 86692 $15.66 Antibody; hepatitis, delta agent 86694 $13.13 Antibody; herpes simplex, non-specific type test 86695 $12.03 Antibody; herpes simplex, type 1 86696 $17.66 Antibody; herpes simplex, type 2 86698 $11.40 Antibody; histoplasma 86701 $8.11 Antibody; HIV-1 86702 $12.33 Antibody; HIV-2 86703 $12.50 Antibody; HIV-1 and HIV-2, single result 86704 $10.99 Hepatitis B core antibody (HbcAb); total 86705 $10.74 Hepatitis B core antibody (HbcAb); IgM antibody 86706 $9.80 Hepatitis B surface antibody (HbsAb) 86707 $10.55 Hepatitis Be antibody (HbeAb) 86708 $11.30 Hepatitis A antibody (HAAb)

33

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description 86709 $10.27 Hepatitis A antibody (HAAb), IgM antibody 86710 $12.36 Antibody; influenza virus 86711 $13.13 Antibody; JC (John Cunningham) virus 86713 $13.96 Antibody; Legionella 86717 $11.17 Antibody; Leishmania 86720 $12.03 Antibody; Leptospira 86723 $12.03 Antibody; Listeria monocytogenes 86727 $11.74 Antibody; lymphocytic choriomeningitis 86732 $12.03 Antibody; mucormycosis 86735 $11.90 Antibody; mumps 86738 $12.07 Antibody; mycoplasma 86741 $12.03 Antibody; Neisseria meningitidis 86744 $12.03 Antibody; Nocardia 86747 $13.71 Antibody; parvovirus 86750 $12.03 Antibody; Plasmodium (malaria) 86753 $11.30 Antibody; protozoa, not elsewhere specified 86756 $11.76 Antibody; respiratory syncytial virus 86757 $17.66 Antibody; Rickettsia 86759 $13.47 Antibody; rotavirus 86762 $13.13 Antibody; rubella 86765 $11.75 Antibody; rubeola 86768 $12.03 Antibody; Salmonella Antibody; severe acute respiratory syndrome 86769 $42.13 coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) 86771 $18.09 Antibody; Shigella 86774 $13.50 Antibody; tetanus 86777 $13.13 Antibody; Toxoplasma 86778 $13.14 Antibody; Toxoplasma, IgM 86780 $12.07 Antibody; Treponema pallidum 86784 $11.46 Antibody; Trichinella 86787 $11.75 Antibody; varicella-zoster 86788 $15.37 Antibody; West Nile virus, IgM 86789 $13.13 Antibody; West Nile virus 86790 $11.75 Antibody; virus, not elsewhere specified 86793 $12.03 Antibody; Yersinia 86794 $15.37 Antibody; Zika virus, IgM

34

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description 86800 $14.51 Thyroglobulin antibody 86803 $13.01 Hepatitis C antibody Hepatitis C antibody; confirmatory test (e.g., 86804 $14.13 immunoblot) Lymphocytotoxicity assay, visual crossmatch; with 86805 $140.02 titration Lymphocytotoxicity assay, visual crossmatch; without 86806 $43.41 titration Serum screening for cytotoxic percent reactive 86807 $58.11 antibody (PRA); standard method Serum screening for cytotoxic percent reactive 86808 $27.07 antibody (PRA); quick method HLA typing; A, B, or C (e.g., A10, B7, B27), single 86812 $23.54 antigen 86813 $52.90 HLA typing; A, B, or C, multiple antigens 86816 $25.41 HLA typing; DR/DQ, single antigen 86817 $78.42 HLA typing; DR/DQ, multiple antigens 86821 $33.35 HLA typing; lymphocyte culture, mixed (MLC) Human leukocyte antigen (HLA) crossmatch, non- 86825 $80.90 cytotoxic (e.g., using flow cytometry); first serum sample or dilution Human leukocyte antigen (HLA) crossmatch, non- cytotoxic (e.g., using flow cytometry); each additional 86826 $26.99 serum sample or sample dilution (List separately in addition to primary procedure) Antibody to human leukocyte antigens (HLA), solid phase assays (e.g., microspheres or beads, ELISA, flow 86828 $47.43 cytometry); qualitative assessment of the presence or absence of antibody(ies) to HLA Class I and Class II HLA antigens Antibody to human leukocyte antigens (HLA), solid phase assays (e.g., microspheres or beads, ELISA, 86829 $47.43 Flow cytometry); qualitative assessment of the presence or absence of antibody(ies) to HLA Class I or Class II HLA antigens Antibody to human leukocyte antigens (HLA), solid phase assays (e.g., microspheres or beads, ELISA, 86830 $73.65 Flow cytometry); antibody identification by qualitative panel using complete HLA phenotypes, HLA Class I Antibody to human leukocyte antigens (HLA), solid phase assays (e.g., microspheres or beads, ELISA, 86831 $63.13 Flow cytometry); antibody identification by qualitative panel using complete HLA phenotypes, HLA Class II

35

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Antibody to human leukocyte antigens (HLA), solid phase assays (e.g., microspheres or beads, ELISA, 86832 $239.21 Flow cytometry); high definition qualitative panel for identification of antibody specificities (e.g., individual antigen per bead methodology), HLA Class I Antibody to human leukocyte antigens (HLA), solid phase assays (e.g., microspheres or beads, ELISA, 86833 $240.72 Flow cytometry); high definition qualitative panel for identification of antibody specificities (e.g., individual antigen per bead methodology), HLA Class II Antibody to human leukocyte antigens (HLA), solid phase assays (e.g., microspheres or beads, ELISA, 86834 $326.15 Flow cytometry); semi-quantitative panel (e.g., titer), HLA Class I Antibody to human leukocyte antigens (HLA), solid phase assays (e.g., microspheres or beads, ELISA, 86835 $294.60 Flow cytometry); semi-quantitative panel (e.g., titer), HLA Class II 86849 I.C. Unlisted immunology procedure Transformation 86850 $7.22 Antibody screen, RBC, each serum technique 86860 I.C. Antibody elution (RBC), each elution Antibody identification, RBC antibodies, each panel 86870 I.C. for each serum technique Antihuman globulin test (Coombs test); direct, each 86880 $4.91 antiserum Antihuman globulin test (Coombs test); indirect, 86885 $5.22 qualitative, each reagent red cell Antihuman globulin test (Coombs test); indirect, each 86886 $4.72 antibody titer Autologous blood or component, collection processing 86890 I.C. and storage; predeposited Autologous blood or component, collection processing 86891 I.C. and storage; intra- or postoperative salvage 86900 $2.73 Blood typing, serologic; ABO 86901 $2.73 Blood typing, serologic; Rh (D) Blood typing, serologic; antigen testing of donor blood 86902 $4.69 using reagent serum, each antigen test Blood typing, serologic; antigen screening for 86904 $12.07 compatible unit using patient serum, per unit screened Blood typing, serologic; RBC antigens, other than 86905 $3.49 ABO or Rh (D), each

36

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description 86906 $7.07 Blood typing, serologic; Rh phenotyping, complete 86920 I.C. Compatibility test each unit; immediate spin technique 86921 I.C. Compatibility test each unit; incubation technique 86922 I.C. Compatibility test each unit; antiglobulin technique 86923 I.C. Compatibility test each unit; electronic 86927 I.C. Fresh frozen plasma, thawing, each unit Frozen blood, each unit; freezing (includes 86930 I.C. preparation) 86931 I.C. Frozen blood, each unit; thawing Frozen blood, each unit; freezing (includes 86932 I.C. preparation) and thawing 86940 $7.48 Hemolysins and agglutinins; auto, screen, each 86941 $11.05 Hemolysins and agglutinins; incubated 86945 $23.15 Irradiation of blood product, each unit Volume reduction of blood or blood product (e.g., red 86960 I.C. blood cells or platelets), each unit 86965 $23.15 Pooling of platelets or other blood products Pretreatment of RBCs for use in RBC antibody 86970 $18.50 detection, identification, and/or compatibility testing; incubation with chemical agents or drugs, each Pretreatment of RBCs for use in RBC antibody 86971 $18.50 detection, identification, and/or compatibility testing; incubation with enzymes, each Pretreatment of serum for use in RBC antibody 86976 $18.50 identification; by dilution Pretreatment of serum for use in RBC antibody 86977 $18.50 identification; incubation with inhibitors, each Pretreatment of serum for use in RBC antibody identification; by differential red cell absorption using 86978 $18.50 patient RBCs or RBCs of known phenotype, each absorption 86985 I.C. Splitting of blood or blood products, each unit 86999 I.C. Unlisted transfusion medicine procedure Microbiology Animal inoculation, small animal, with observation 87003 $15.36 and dissection 87015 $6.09 Concentration (any type), for infectious agents Culture, bacterial; blood, aerobic, with isolation and 87040 $9.41 presumptive identification of isolates (includes anaerobic culture, if appropriate)

37

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Culture, bacterial; stool, aerobic, with isolation and 87045 $8.62 preliminary examination (e.g., KIA, LIA), Salmonella and Shigella species Culture, bacterial; stool, aerobic, additional pathogens, 87046 $8.62 isolation and presumptive identification of isolates, each plate Culture, bacterial; any other source except urine, blood 87070 $7.86 or stool, aerobic, with isolation and presumptive identification of isolates Culture, bacterial; quantitative, aerobic with isolation 87071 $8.62 and presumptive identification of isolates, any source except urine, blood or stool Culture, bacterial; quantitative, anaerobic with 87073 $8.62 isolation and presumptive identification of isolates, any source except urine, blood or stool Culture, bacterial; any source, except blood, anaerobic 87075 $8.64 with isolation and presumptive identification of isolates Culture, bacterial; anaerobic isolate, additional 87076 $7.37 methods required for definitive identification, each isolate Culture, bacterial; aerobic isolate, additional methods 87077 $7.37 required for definitive identification, each isolate Culture, presumptive, pathogenic organisms, screening 87081 $6.04 only Culture, presumptive, pathogenic organisms, screening 87084 $20.00 only; with colony estimation from density chart 87086 $7.36 Culture, bacterial; quantitative colony count, urine Culture, bacterial; with isolation and presumptive 87088 $7.38 identification of each isolate, urine Culture, fungi (mold or yeast) isolation, with 87101 $7.03 presumptive identification of isolates; skin, hair, or nail Culture, fungi (mold or yeast) isolation, with 87102 $7.67 presumptive identification of isolates; other source (except blood) Culture, fungi (mold or yeast) isolation, with 87103 $15.12 presumptive identification of isolates; blood Culture, fungi, definitive identification, each organism; 87106 $9.41 yeast Culture, fungi, definitive identification, each organism; 87107 $9.41 mold 87109 $14.04 Culture, mycoplasma, any source 87110 $17.87 Culture, chlamydia, any source

38

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Culture, tubercle or other acid-fast bacilli (e.g., TB, 87116 $9.86 AFB, mycobacteria) any source, with isolation and presumptive identification of isolates Culture, mycobacterial, definitive identification, each 87118 $10.79 isolate Culture, typing; immunofluorescent method, each 87140 $5.08 antiserum Culture, typing; gas liquid chromatography (GLC) or 87143 $11.42 high pressure liquid chromatography (HPLC) method Culture, typing; immunologic method, other than 87147 $4.72 immunofluorescence (e.g., agglutination grouping), per antiserum Culture, typing; identification by nucleic acid (DNA or 87149 $18.29 RNA) probe, direct probe technique, per culture or isolate, each organism probed Culture, typing; identification by nucleic acid (DNA or 87150 $32.01 RNA) probe, amplified probe technique, per culture or isolate, each organism probed 87152 $5.72 Culture, typing; identification by pulse field gel typing 87158 $5.72 Culture, typing; other methods Dark field examination, any source (e.g., penile, 87164 $9.80 vaginal, oral, skin); includes specimen collection Dark field examination, any source (e.g., penile, 87166 $10.31 vaginal, oral, skin); without collection 87168 $3.89 Macroscopic examination; arthropod 87169 $3.89 Macroscopic examination; parasite 87172 $3.89 Pinworm exam (e.g., cellophane tape prep) 87176 $5.36 Homogenization, tissue, for culture Ova and parasites, direct smears, concentration and 87177 $8.12 identification Susceptibility studies, antimicrobial agent; agar 87181 $4.33 dilution method, per agent (e.g., antibiotic gradient strip) Susceptibility studies, antimicrobial agent; disk 87184 $6.29 method, per plate (12 or fewer agents) Susceptibility studies, antimicrobial agent; enzyme 87185 $4.33 detection (e.g., beta lactamase), per enzyme Susceptibility studies, antimicrobial agent; microdilution or agar dilution (minimum inhibitory 87186 $7.88 concentration [MIC] or breakpoint), each multi- antimicrobial, per plate

39

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Susceptibility studies, antimicrobial agent; microdilution or agar dilution, minimum lethal 87187 $29.68 concentration (MLC), each plate (List separately in addition to code for primary procedure) Susceptibility studies, antimicrobial agent; macrobroth 87188 $6.06 dilution method, each agent Susceptibility studies, antimicrobial agent; 87190 $5.40 mycobacteria, proportion method, each agent 87197 $13.71 Serum bactericidal titer (Schlichter test) Smear, primary source with interpretation; Gram or 87205 $3.89 Giemsa stain for bacteria, fungi, or cell types Smear, primary source with interpretation; fluorescent 87206 $4.91 and/or acid fast stain for bacteria, fungi, parasites, viruses or cell types Smear, primary source with interpretation; special stain 87207 $5.47 for inclusion bodies or parasites (e.g., malaria, coccidia, microsporidia, trypanosomes, herpes viruses) Smear, primary source with interpretation; complex 87209 $16.40 special stain (e.g., trichrome, iron hemotoxylin) for ova and parasites Smear, primary source with interpretation; wet mount 87210 $4.30 for infectious agents (e.g., saline, India ink, KOH preps) Tissue examination by KOH slide of samples from 87220 $3.89 skin, hair, or nails for fungi or ectoparasite ova or mites (e.g., scabies) Toxin or antitoxin assay, tissue culture (e.g., 87230 $18.01 Clostridium difficile toxin) Virus isolation; inoculation of embryonated eggs, or 87250 $17.84 small animal, includes observation and dissection Virus isolation; tissue culture inoculation, observation, 87252 $23.78 and presumptive identification by cytopathic effect Virus isolation; tissue culture, additional studies or 87253 $18.43 definitive identification (e.g., hemabsorption, neutralization, immunofluorescence stain), each isolate Virus isolation; centrifuge enhanced (shell vial) 87254 $17.84 technique, includes identification with immunofluorescence stain, each virus Virus isolation; including identification by non- 87255 $30.89 immunologic method, other than by cytopathic effect (e.g., virus specific enzymatic activity) Infectious agent antigen detection by 87260 $10.94 immunofluorescent technique; adenovirus

40

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Infectious agent antigen detection by 87265 $10.94 immunofluorescent technique; Bordetella pertussis/parapertussis Infectious agent antigen detection by 87267 $10.94 immunofluorescent technique; Enterovirus, direct fluorescent antibody (DFA) Infectious agent antigen detection by 87269 $10.94 immunofluorescent technique; giardia Infectious agent antigen detection by 87270 $10.94 immunofluorescent technique; Chlamydia trachomatis Infectious agent antigen detection by 87271 $10.94 immunofluorescent technique; Cytomegalovirus, direct fluorescent antibody (DFA) Infectious agent antigen detection by 87272 $10.94 immunofluorescent technique; cryptosporidium Infectious agent antigen detection by 87273 $10.94 immunofluorescent technique; Herpes simplex virus type 2 Infectious agent antigen detection by 87274 $10.94 immunofluorescent technique; Herpes simplex virus type 1 Infectious agent antigen detection by 87275 $10.94 immunofluorescent technique; influenza B virus Infectious agent antigen detection by 87276 $11.87 immunofluorescent technique; influenza A virus Infectious agent antigen detection by 87278 $11.53 immunofluorescent technique; Legionella pneumophila Infectious agent antigen detection by 87279 $12.14 immunofluorescent technique; Parainfluenza virus, each type Infectious agent antigen detection by 87280 $10.94 immunofluorescent technique; respiratory syncytial virus Infectious agent antigen detection by 87281 $10.94 immunofluorescent technique; Pneumocystis carinii Infectious agent antigen detection by 87283 $44.92 immunofluorescent technique; Rubeola Infectious agent antigen detection by 87285 $10.94 immunofluorescent technique; Treponema pallidum Infectious agent antigen detection by 87290 $10.94 immunofluorescent technique; Varicella zoster virus Infectious agent antigen detection by 87299 $11.90 immunofluorescent technique; not otherwise specified, each organism

41

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Infectious agent antigen detection by 87300 $10.94 immunofluorescent technique; polyvalent for multiple organisms, each polyvalent antiserum Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- linked immunosorbent assay [ELISA], 87301 $10.94 immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; adenovirus enteric types 40/41 Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- 87305 $10.94 linked immunosorbent assay [ELISA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; Aspergillus Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- linked immunosorbent assay [ELISA], 87320 $11.08 immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; Chlamydia trachomatis Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- linked immunosorbent assay [ELISA], 87324 $10.94 immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; Clostridium difficile toxin(s) Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- linked immunosorbent assay [ELISA], 87327 $10.94 immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; Cryptococcus neoformans Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- linked immunosorbent assay [ELISA], 87328 $10.94 immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; cryptosporidium Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- 87329 $10.94 linked immunosorbent assay [ELISA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; giardia

42

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- linked immunosorbent assay [ELISA], 87332 $10.94 immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; cytomegalovirus Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- linked immunosorbent assay [ELISA], 87335 $10.94 immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; Escherichia coli 0157 Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- linked immunosorbent assay [ELISA], 87336 $11.82 immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; Entamoeba histolytica dispar group Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- linked immunosorbent assay [ELISA], 87337 $10.94 immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; Entamoeba histolytica group Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- linked immunosorbent assay [ELISA], 87338 $13.12 immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; Helicobacter pylori, stool Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- linked immunosorbent assay [ELISA], 87339 $11.82 immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; Helicobacter pylori Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- linked immunosorbent assay [ELISA], 87340 $9.42 immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; hepatitis B surface antigen (HbsAg)

43

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- linked immunosorbent assay [ELISA], 87341 $9.42 immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; hepatitis B surface antigen (HbsAg) neutralization Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- linked immunosorbent assay [ELISA], 87350 $10.51 immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; hepatitis Be antigen (HbeAg) Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- linked immunosorbent assay [ELISA], 87380 $14.97 immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; hepatitis, delta agent Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- linked immunosorbent assay [ELISA], 87385 $10.94 immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; Histoplasma capsulatum Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- linked immunosorbent assay [ELISA], 87389 $21.97 immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; HIV-1 antigen(s), with HIV-1 and HIV-2 antibodies, single result Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- 87390 $17.78 linked immunosorbent assay [ELISA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; HIV-1 Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- 87391 $16.18 linked immunosorbent assay [ELISA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; HIV-2

44

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- linked immunosorbent assay [ELISA], 87400 $10.94 immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; Influenza, A or B, each Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- linked immunosorbent assay [ELISA], 87420 $10.94 immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; respiratory syncytial virus Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- 87425 $10.94 linked immunosorbent assay [ELISA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; rotavirus Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- linked immunosorbent assay [ELISA], 87426 $10.94 immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; severe acute respiratory syndrome coronavirus (e.g., SARS-CoV, SARS-CoV-2 [COVID-19]) Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- linked immunosorbent assay [ELISA], 87427 $10.94 immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; Shiga-like toxin Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay 87428 I.C. [IMCA]) qualitative or semiquantitative; severe acute respiratory syndrome coronavirus (e.g., SARS-CoV, SARS-CoV-2 [COVID-19]) and influenza virus types A and B Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- linked immunosorbent assay [ELISA], 87430 $12.42 immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; Streptococcus, group A

45

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- linked immunosorbent assay [ELISA], 87449 $10.94 immunochemiluminometric assay [IMCA]), qualitative or semiquantitative; multiple-step method, not otherwise specified, each organism Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- linked immunosorbent assay [ELISA], 87450 $8.75 immunochemiluminometric assay [IMCA]), qualitative or semiquantitative; single step method, not otherwise specified, each organism Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme- linked immunosorbent assay [ELISA], 87451 $8.75 immunochemiluminometric assay [IMCA]), qualitative or semiquantitative; multiple step method, polyvalent for multiple organisms, each polyvalent antiserum Infectious agent detection by nucleic acid (DNA or 87471 $32.01 RNA); Bartonella henselae and Bartonella quintana, amplified probe technique Infectious agent detection by nucleic acid (DNA or 87472 $39.07 RNA); Bartonella henselae and Bartonella quintana, quantification Infectious agent detection by nucleic acid (DNA or 87475 $18.29 RNA); Borrelia burgdorferi, direct probe technique Infectious agent detection by nucleic acid (DNA or 87476 $32.01 RNA); Borrelia burgdorferi, amplified probe technique Infectious agent detection by nucleic acid (DNA or 87480 $18.29 RNA); Candida species, direct probe technique Infectious agent detection by nucleic acid (DNA or 87481 $32.01 RNA); Candida species, amplified probe technique Infectious agent detection by nucleic acid (DNA or 87482 $41.18 RNA); Candida species, quantification Infectious agent detection by nucleic acid (DNA or RNA); central nervous system pathogen (e.g., Neisseria meningitidis, Streptococcus pneumoniae, Listeria, Haemophilus influenza, E. coli, Streptococcus agalactiae, enterovirus, human parechovirus, herpes 87483 $380.18 simplex virus type 1 and 2, human herpesvirus 6, cytomegalovirus, varicella zoster virus, Cryptococcus), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 12-25 targets

46

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Infectious agent detection by nucleic acid (DNA or 87485 $18.29 RNA); Chlamydia pneumoniae, direct probe technique Infectious agent detection by nucleic acid (DNA or 87486 $32.01 RNA); Chlamydia pneumoniae, amplified probe technique Infectious agent detection by nucleic acid (DNA or 87487 $39.07 RNA); Chlamydia pneumoniae, quantification Infectious agent detection by nucleic acid (DNA or 87490 $18.29 RNA); Chlamydia trachomatis, direct probe technique Infectious agent detection by nucleic acid (DNA or 87491 $32.01 RNA); Chlamydia trachomatis, amplified probe technique Infectious agent detection by nucleic acid (DNA or 87492 $39.51 RNA); Chlamydia trachomatis, quantification Infectious agent detection by nucleic acid (DNA or 87493 $32.01 RNA); Clostridium difficile, toxin gene(s), amplified probe technique Infectious agent detection by nucleic acid (DNA or 87495 $22.19 RNA); cytomegalovirus, direct probe technique Infectious agent detection by nucleic acid (DNA or 87496 $32.01 RNA); cytomegalovirus, amplified probe technique Infectious agent detection by nucleic acid (DNA or 87497 $39.07 RNA); cytomegalovirus, quantification Infectious agent detection by nucleic acid (DNA or 87498 $32.01 RNA); enterovirus, amplified probe technique, includes reverse transcription when performed Infectious agent detection by nucleic acid (DNA or 87500 $32.01 RNA); vancomycin resistance (e.g., enterococcus species van A, van B), amplified probe technique Infectious agent detection by nucleic acid (DNA or RNA); influenza virus, includes reverse transcription, 87501 $46.81 when performed, and amplified probe technique, each type or subtype Infectious agent detection by nucleic acid (DNA or RNA); influenza virus, for multiple types or sub-types, 87502 $77.62 includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, first 2 types or sub-types

47

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Infectious agent detection by nucleic acid (DNA or RNA); influenza virus, for multiple types or sub-types, includes multiplex reverse transcription, when 87503 $21.59 performed, and multiplex amplified probe technique, each additional influenza virus type or sub-type beyond 2 (List separately in addition to code for primary procedure) Infectious agent detection by nucleic acid (DNA or RNA); gastrointestinal pathogen (e.g., Clostridium difficile, E. coli, Salmonella, Shigella, norovirus, 87505 $117.02 Giardia), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 3-5 targets Infectious agent detection by nucleic acid (DNA or RNA); gastrointestinal pathogen (e.g., Clostridium difficile, E. coli, Salmonella, Shigella, norovirus, 87506 $194.68 Giardia), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 6-11 targets Infectious agent detection by nucleic acid (DNA or RNA); gastrointestinal pathogen (e.g., Clostridium difficile, E. coli, Salmonella, Shigella, norovirus, 87507 $380.18 Giardia), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 12-25 targets Infectious agent detection by nucleic acid (DNA or 87510 $18.29 RNA); Gardnerella vaginalis, direct probe technique Infectious agent detection by nucleic acid (DNA or 87511 $32.01 RNA); Gardnerella vaginalis, amplified probe technique Infectious agent detection by nucleic acid (DNA or 87512 $38.09 RNA); Gardnerella vaginalis, quantification Infectious agent detection by nucleic acid (DNA or 87516 $32.01 RNA); hepatitis B virus, amplified probe technique Infectious agent detection by nucleic acid (DNA or 87517 $39.07 RNA); hepatitis B virus, quantification Infectious agent detection by nucleic acid (DNA or 87520 $23.07 RNA); hepatitis C, direct probe technique Infectious agent detection by nucleic acid (DNA or 87521 $32.01 RNA); hepatitis C, amplified probe technique, includes reverse transcription when performed Infectious agent detection by nucleic acid (DNA or 87522 $39.07 RNA); hepatitis C, quantification, includes reverse transcription when performed

48

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Infectious agent detection by nucleic acid (DNA or 87525 $22.02 RNA); hepatitis G, direct probe technique Infectious agent detection by nucleic acid (DNA or 87526 $32.01 RNA); hepatitis G, amplified probe technique Infectious agent detection by nucleic acid (DNA or 87527 $38.09 RNA); hepatitis G, quantification Infectious agent detection by nucleic acid (DNA or 87528 $18.29 RNA); Herpes simplex virus, direct probe technique Infectious agent detection by nucleic acid (DNA or 87529 $32.01 RNA); Herpes simplex virus, amplified probe technique Infectious agent detection by nucleic acid (DNA or 87530 $39.07 RNA); Herpes simplex virus, quantification Infectious agent detection by nucleic acid (DNA or 87531 $42.85 RNA); Herpes virus-6, direct probe technique Infectious agent detection by nucleic acid (DNA or 87532 $32.01 RNA); Herpes virus-6, amplified probe technique Infectious agent detection by nucleic acid (DNA or 87533 $38.09 RNA); Herpes virus-6, quantification Infectious agent detection by nucleic acid (DNA or 87534 $18.29 RNA); HIV-1, direct probe technique Infectious agent detection by nucleic acid (DNA or 87535 $32.01 RNA); HIV-1, amplified probe technique, includes reverse transcription when performed Infectious agent detection by nucleic acid (DNA or 87536 $77.62 RNA); HIV-1, quantification, includes reverse transcription when performed Infectious agent detection by nucleic acid (DNA or 87537 $18.29 RNA); HIV-2, direct probe technique Infectious agent detection by nucleic acid (DNA or 87538 $32.01 RNA); HIV-2, amplified probe technique, includes reverse transcription when performed Infectious agent detection by nucleic acid (DNA or 87539 $43.31 RNA); HIV-2, quantification, includes reverse transcription when performed Infectious agent detection by nucleic acid (DNA or 87540 $18.29 RNA); Legionella pneumophila, direct probe technique Infectious agent detection by nucleic acid (DNA or 87541 $32.01 RNA); Legionella pneumophila, amplified probe technique Infectious agent detection by nucleic acid (DNA or 87542 $38.09 RNA); Legionella pneumophila, quantification Infectious agent detection by nucleic acid (DNA or 87550 $18.29 RNA); Mycobacteria species, direct probe technique

49

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Infectious agent detection by nucleic acid (DNA or 87551 $35.64 RNA); Mycobacteria species, amplified probe technique Infectious agent detection by nucleic acid (DNA or 87552 $39.07 RNA); Mycobacteria species, quantification Infectious agent detection by nucleic acid (DNA or 87555 $19.86 RNA); Mycobacteria tuberculosis, direct probe technique Infectious agent detection by nucleic acid (DNA or 87556 $32.01 RNA); Mycobacteria tuberculosis, amplified probe technique Infectious agent detection by nucleic acid (DNA or 87557 $39.07 RNA); Mycobacteria tuberculosis, quantification Infectious agent detection by nucleic acid (DNA or 87560 $20.16 RNA); Mycobacteria avium-intracellulare, direct probe technique Infectious agent detection by nucleic acid (DNA or 87561 $32.01 RNA); Mycobacteria avium-intracellulare, amplified probe technique Infectious agent detection by nucleic acid (DNA or 87562 $39.07 RNA); Mycobacteria avium-intracellulare, quantification Infectious agent detection by nucleic acid (DNA or 87563 $25.93 RNA); Mycoplasma genitalium, amplified probe technique Infectious agent detection by nucleic acid (DNA or 87580 $18.29 RNA); Mycoplasma pneumoniae, direct probe technique Infectious agent detection by nucleic acid (DNA or 87581 $32.01 RNA); Mycoplasma pneumoniae, amplified probe technique Infectious agent detection by nucleic acid (DNA or 87582 $223.59 RNA); Mycoplasma pneumoniae, quantification Infectious agent detection by nucleic acid (DNA or 87590 $19.86 RNA); Neisseria gonorrhoeae, direct probe technique Infectious agent detection by nucleic acid (DNA or 87591 $32.01 RNA); Neisseria gonorrhoeae, amplified probe technique Infectious agent detection by nucleic acid (DNA or 87592 $39.07 RNA); Neisseria gonorrhoeae, quantification Infectious agent detection by nucleic acid (DNA or 87623 $32.01 RNA); Human Papillomavirus (HPV), low-risk types (e.g., 6, 11, 42, 43, 44)

50

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Infectious agent detection by nucleic acid (DNA or 87624 $32.01 RNA); Human Papillomavirus (HPV), high-risk types (e.g., 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68) Infectious agent detection by nucleic acid (DNA or 87625 $32.01 RNA); Human Papillomavirus (HPV), types 16 and 18 only, includes type 45, if performed Infectious agent detection by nucleic acid (DNA or RNA); respiratory virus (e.g., adenovirus, influenza virus, coronavirus, metapneumovirus, parainfluenza 87631 $117.02 virus, respiratory syncytial virus, rhinovirus), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 3-5 targets Infectious agent detection by nucleic acid (DNA or RNA); respiratory virus (e.g., adenovirus, influenza virus, coronavirus, metapneumovirus, parainfluenza 87632 $194.68 virus, respiratory syncytial virus, rhinovirus), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 6-11 targets Infectious agent detection by nucleic acid (DNA or RNA); respiratory virus (e.g., adenovirus, influenza virus, coronavirus, metapneumovirus, parainfluenza 87633 $380.18 virus, respiratory syncytial virus, rhinovirus), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 12-25 targets Infectious agent detection by nucleic acid (DNA or 87634 $64.03 RNA); respiratory syncytial virus, amplified probe technique Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 87635 $51.31 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique 87636 I.C. Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) and influenza virus types A and B, multiplex amplified probe technique 87637 I.C. Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), influenza virus types A and B, and respiratory syncytial virus, multiplex amplified probe technique

51

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Infectious agent detection by nucleic acid (DNA or 87640 $32.01 RNA); Staphylococcus aureus, amplified probe technique Infectious agent detection by nucleic acid (DNA or 87641 $32.01 RNA); Staphylococcus aureus, methicillin resistant, amplified probe technique Infectious agent detection by nucleic acid (DNA or 87650 $18.29 RNA); Streptococcus, group A, direct probe technique Infectious agent detection by nucleic acid (DNA or 87651 $32.01 RNA); Streptococcus, group A, amplified probe technique Infectious agent detection by nucleic acid (DNA or 87652 $38.09 RNA); Streptococcus, group A, quantification Infectious agent detection by nucleic acid (DNA or 87653 $32.01 RNA); Streptococcus, group B, amplified probe technique Infectious agent detection by nucleic acid (DNA or 87660 $18.29 RNA); Trichomonas vaginalis, direct probe technique Infectious agent detection by nucleic acid (DNA or 87661 $32.01 RNA); Trichomonas vaginalis, amplified probe technique Infectious agent detection by nucleic acid (DNA or 87662 $46.81 RNA); Zika virus, amplified probe technique Infectious agent detection by nucleic acid (DNA or 87797 $22.19 RNA), not otherwise specified; direct probe technique, each organism Infectious agent detection by nucleic acid (DNA or 87798 $32.01 RNA), not otherwise specified; amplified probe technique, each organism Infectious agent detection by nucleic acid (DNA or 87799 $39.07 RNA), not otherwise specified; quantification, each organism Infectious agent detection by nucleic acid (DNA or 87800 $36.60 RNA), multiple organisms; direct probe(s) technique Infectious agent detection by nucleic acid (DNA or 87801 $64.03 RNA), multiple organisms; amplified probe(s) technique Infectious agent antigen detection by immunoassay 87802 $10.94 with direct optical observation; Streptococcus, group B Infectious agent antigen detection by immunoassay 87803 $11.82 with direct optical observation; Clostridium difficile toxin A Infectious agent antigen detection by immunoassay 87804 $12.23 with direct optical observation; Influenza

52

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Infectious agent antigen detection by immunoassay 87806 $24.21 with direct optical observation; HIV-1 antigen(s), with HIV-1 and HIV-2 antibodies Infectious agent antigen detection by immunoassay 87807 $10.94 with direct optical observation; respiratory syncytial virus Infectious agent antigen detection by immunoassay 87808 $11.30 with direct optical observation; Trichomonas vaginalis Infectious agent antigen detection by immunoassay 87809 $16.08 with direct optical observation; adenovirus Infectious agent antigen detection by immunoassay 87810 $26.07 with direct optical observation; Chlamydia trachomatis 87811 I.C. Infectious agent antigen detection by immunoassay with direct optical (i.e., visual) observation; severe acute respiratory syndrome coronavirus 2 (SARS-CoV- 2) (Coronavirus disease [COVID-19]) Infectious agent antigen detection by immunoassay 87850 $18.15 with direct optical observation; Neisseria gonorrhoeae Infectious agent antigen detection by immunoassay 87880 $12.21 with direct optical observation; Streptococcus, group A Infectious agent antigen detection by immunoassay 87899 $11.87 with direct optical observation; not otherwise specified Infectious agent drug susceptibility phenotype 87900 $118.90 prediction using regularly updated genotypic bioinformatics Infectious agent genotype analysis by nucleic acid 87901 $234.84 (DNA or RNA); HIV-1, reverse transcriptase and protease regions Infectious agent genotype analysis by nucleic acid 87902 $234.84 (DNA or RNA); Hepatitis C virus Infectious agent phenotype analysis by nucleic acid 87903 $445.74 (DNA or RNA) with drug resistance tissue culture analysis, HIV 1; first through 10 drugs tested Infectious agent phenotype analysis by nucleic acid (DNA or RNA) with drug resistance tissue culture 87904 $23.78 analysis, HIV 1; each additional drug tested (List separately in addition to code for primary procedure) Infectious agent enzymatic activity other than virus 87905 $11.14 (e.g., sialidase activity in vaginal fluid) Infectious agent genotype analysis by nucleic acid 87906 $117.42 (DNA or RNA); HIV-1, other region (e.g., integrase, fusion) Infectious agent genotype analysis by nucleic acid 87910 $234.84 (DNA or RNA); cytomegalovirus

53

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Infectious agent genotype analysis by nucleic acid 87912 $234.84 (DNA or RNA); Hepatitis B virus 87999 I.C. Unlisted microbiology procedure Anatomic Pathology Necropsy (autopsy), gross examination only; without 88000 I.C. CNS Necropsy (autopsy), gross examination only; with 88005 I.C. brain Necropsy (autopsy), gross examination only; with 88007 I.C. brain and spinal cord Necropsy (autopsy), gross examination only; infant 88012 I.C. with brain Necropsy (autopsy), gross examination only; stillborn 88014 I.C. or newborn with brain Necropsy (autopsy), gross examination only; 88016 I.C. macerated stillborn Necropsy (autopsy), gross and microscopic; without 88020 I.C. CNS 88025 I.C. Necropsy (autopsy), gross and microscopic; with brain Necropsy (autopsy), gross and microscopic; with brain 88027 I.C. and spinal cord Necropsy (autopsy), gross and microscopic; infant with 88028 I.C. brain Necropsy (autopsy), gross and microscopic; stillborn or 88029 I.C. newborn with brain Necropsy (autopsy), limited, gross and/or microscopic; 88036 I.C. regional Necropsy (autopsy), limited, gross and/or microscopic; 88037 I.C. single organ 88040 I.C. Necropsy (autopsy); forensic examination 88045 I.C. Necropsy (autopsy); coroner’s call 88099 I.C. Unlisted necropsy (autopsy) procedure Cytopathology 88130 $16.40 Sex chromatin identification; Barr bodies Sex chromatin identification; peripheral blood smear, 88140 $7.29 polymorphonuclear drumsticks Cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin 88142 $18.48 layer preparation; manual screening under physician supervision

54

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin 88143 $18.48 layer preparation; with manual screening and rescreening under physician supervision Cytopathology smears, cervical or vaginal; screening 88147 $37.36 by automated system under physician supervision Cytopathology smears, cervical or vaginal; screening 88148 $13.86 by automated system with manual rescreening under physician supervision Cytopathology, slides, cervical or vaginal; manual 88150 $10.82 screening under physician supervision Cytopathology, slides, cervical or vaginal; with manual 88152 $20.42 screening and computer-assisted rescreening under physician supervision Cytopathology, slides, cervical or vaginal; with manual 88153 $17.75 screening and rescreening under physician supervision Cytopathology, slides, cervical or vaginal; definitive hormonal evaluation (e.g., maturation index, 88155 $10.82 karyopyknotic index, estrogenic index) (List separately in addition to code[s] for other technical and interpretation services) Cytopathology, slides, cervical or vaginal (the 88164 $10.82 Bethesda System); manual screening under physician supervision Cytopathology, slides, cervical or vaginal (the 88165 $31.19 Bethesda System); with manual screening and rescreening under physician supervision Cytopathology, slides, cervical or vaginal (the Bethesda System); with manual screening and 88166 $10.82 computer-assisted rescreening under physician supervision Cytopathology, slides, cervical or vaginal (the Bethesda System); with manual screening and 88167 $10.82 computer-assisted rescreening using cell selection and review under physician supervision Cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin 88174 $19.49 layer preparation; screening by automated system, under physician supervision Cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, automated thin 88175 $24.17 layer preparation; with screening by automated system and manual rescreening or review, under physician supervision

55

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Cytogenic Studies Tissue culture for non-neoplastic disorders; 88230 $106.26 lymphocyte Tissue culture for non-neoplastic disorders; skin or 88233 $128.37 other solid tissue biopsy Tissue culture for non-neoplastic disorders; amniotic 88235 $134.33 fluid or chorionic villus cells Tissue culture for neoplastic disorders; bone marrow, 88237 $115.21 blood cells 88239 $134.56 Tissue culture for neoplastic disorders; solid tumor Cryopreservation, freezing and storage of cells, each 88240 $9.66 cell line 88241 $9.21 Thawing and expansion of frozen cells, each aliquot analysis for breakage syndromes; 88245 $157.97 baseline Sister Chromatid Exchange (SCE), 20-25 cells Chromosome analysis for breakage syndromes; baseline breakage, score 50-100 cells, count 20 cells, 2 88248 $157.97 karyotypes (e.g., for ataxia telangiectasia, Fanconi anemia, fragile X) Chromosome analysis for breakage syndromes; score 88249 $157.97 100 cells, clastogen stress (e.g., diepoxybutane, mitomycin C, ionizing radiation, UV radiation) Chromosome analysis; count 5 cells, 1 karyotype, with 88261 $195.31 banding Chromosome analysis; count 15-20 cells, 2 karyotypes, 88262 $113.70 with banding Chromosome analysis; count 45 cells for mosaicism, 2 88263 $137.09 karyotypes, with banding 88264 $113.70 Chromosome analysis; analyze 20-25 cells Chromosome analysis; amniotic fluid or chorionic 88267 $163.99 villus, count 15 cells, 1 karyotype, with banding Chromosome analysis; in situ for amniotic fluid cells, 88269 $151.72 count cells from 6-12 colonies, 1 karyotype, with banding 88271 $19.54 Molecular cytogenetics; DNA probe, each (e.g., FISH) Molecular cytogenetics; chromosomal in situ 88272 $30.07 hybridization, analyze 3-5 cells (e.g., for derivatives and markers) Molecular cytogenetics; chromosomal in situ 88273 $29.30 hybridization, analyze 10-30 cells (e.g., for microdeletions)

56

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Molecular cytogenetics; interphase in situ 88274 $31.76 hybridization, analyze 25-99 cells Molecular cytogenetics; interphase in situ 88275 $37.82 hybridization, analyze 100-300 cells Chromosome analysis; additional karyotypes, each 88280 $24.73 study Chromosome analysis; additional specialized banding 88283 $62.57 technique (e.g., NOR, C-banding) Chromosome analysis; additional cells counted, each 88285 $19.88 study 88289 $31.41 Chromosome analysis; additional high resolution study Protein analysis of tissue by Western Blot, with 88371 $20.27 interpretation and report Protein analysis of tissue by Western Blot, with 88372 $20.75 interpretation and report; immunological probe for band identification, each In vivo, (e.g., Transcutaneous) Laboratory Procedures 88720 $4.57 Bilirubin, total, transcutaneous 88738 $4.57 Hemoglobin (Hgb), quantitative, transcutaneous Hemoglobin, quantitative, transcutaneous, per day; 88740 $6.92 carboxyhemoglobin Hemoglobin, quantitative, transcutaneous, per day; 88741 $6.92 methemoglobin Other Procedures Cell count, miscellaneous body fluids (e.g., 89050 $4.31 cerebrospinal fluid, joint fluid), except blood; Cell count, miscellaneous body fluids (e.g., 89051 $5.02 cerebrospinal fluid, joint fluid), except blood; with differential count Leukocyte assessment, fecal, qualitative or 89055 $3.89 semiquantitative Crystal identification by light microscopy with or 89060 $6.52 without polarizing lens analysis, tissue or any body fluid (except urine) 89125 $4.34 Fat stain, feces, urine, or respiratory secretions 89160 $3.58 Meat fibers, feces 89190 $4.33 Nasal smear for eosinophils Reproductive Medicine Procedures 89250 I.C. Culture of oocyte(s)/embryo(s), less than 4 days Culture of oocyte(s)/embryo(s), less than 4 days; with 89251 I.C. co-culture of oocyte(s)/embryos

57

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Assisted embryo hatching, microtechniques (any 89253 I.C. method) 89254 I.C. Oocyte identification from follicular fluid 89255 I.C. Preparation of embryo for transfer (any method) Sperm identification from aspiration (other than 89257 I.C. seminal fluid) 89258 I.C. Cryopreservation; embryo(s) 89259 I.C. Cryopreservation; sperm Sperm identification from testis tissue, fresh or 89264 I.C. cryopreserved 89268 I.C. Insemination of oocytes 89272 I.C. Extended culture of oocyte(s)/embryo(s), 4-7 days Assisted oocyte fertilization, microtechnique; less than 89280 I.C. or equal to 10 oocytes Assisted oocyte fertilization, microtechnique; greater 89281 I.C. than 10 oocytes Biopsy, oocyte polar body or embryo blastomere, 89290 I.C. microtechnique (for pre-implantation genetic diagnosis); less than or equal to 5 embryos Biopsy, oocyte polar body or embryo blastomere, 89291 I.C. microtechnique (for pre-implantation genetic diagnosis); greater than 5 embryos Semen analysis; presence and/or motility of sperm 89300 $8.15 including Huhner test (post coital) Semen analysis; motility and count (not including 89310 $7.85 Huhner test) Semen analysis; volume, count, motility, and 89320 $10.99 differential Semen analysis; sperm presence and motility of sperm, 89321 $10.99 if performed Semen analysis; volume, count, motility, and 89322 $14.13 differential using strict morphologic criteria (e.g., Kruger) 89325 $9.74 Sperm antibodies 89329 $17.87 Sperm evaluation; hamster penetration test Sperm evaluation; cervical mucus penetration test, with 89330 $9.02 or without spinnbarkeit test Sperm evaluation, for retrograde ejaculation, urine 89331 $17.87 (sperm concentration, motility, and morphology, as indicated) 89335 I.C. Cryopreservation, reproductive tissue, testicular 89342 I.C. Storage (per year); embryo(s)

58

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description 89343 I.C. Storage (per year); sperm/semen Storage (per year); reproductive tissue, 89344 I.C. testicular/ovarian 89346 I.C. Storage (per year); oocyte(s) 89352 I.C. Thawing of cryopreserved; embryo(s) 89353 I.C. Thawing of cryopreserved; sperm/semen, each aliquot Thawing of cryopreserved; reproductive tissue, 89354 I.C. testicular/ovarian 89356 I.C. Thawing of cryopreserved; oocytes, each aliquot 89398 I.C. Unlisted reproductive medicine laboratory procedure Other Pathology and Laboratory 36415 $2.22 Collection of venous blood by venipuncture Urea breath test, C-14 (isotopic); acquisition for 78267 $8.17 analysis 78268 $69.76 Urea breath test, C-14 (isotopic); analysis Human Platelet Antigen 1 genotyping (HPA-1), ITGB3 (integrin, beta 3 [platelet glycoprotein IIIa], antigen 81105 $111.49 CD61 [GPIIIa]) (e.g., neonatal alloimmune thrombocytopenia [NAIT], post-transfusion purpura), gene analysis, common variant, HPA-1a/b (L33P) Human Platelet Antigen 2 genotyping (HPA-2), GP1BA (glycoprotein Ib [platelet], alpha polypeptide 81106 $111.49 [GPIba]) (e.g., neonatal alloimmune thrombocytopenia [NAIT], post-transfusion purpura), gene analysis, common variant, HPA-2a/b (T145M) Human Platelet Antigen 3 genotyping (HPA-3), ITGA2B (integrin, alpha 2b [platelet glycoprotein IIb of IIb/IIIa complex], antigen CD41 [GPIIb]) (e.g., 81107 $111.49 neonatal alloimmune thrombocytopenia [NAIT], post- transfusion purpura), gene analysis, common variant, HPA-3a/b (I843S) Human Platelet Antigen 4 genotyping (HPA-4), ITGB3 (integrin, beta 3 [platelet glycoprotein IIIa], antigen 81108 $111.49 CD61 [GPIIIa]) (e.g., neonatal alloimmune thrombocytopenia [NAIT], post-transfusion purpura), gene analysis, common variant, HPA-4a/b (R143Q) Human Platelet Antigen 5 genotyping (HPA-5), ITGA2 (integrin, alpha 2 [CD49B, alpha 2 subunit of VLA-2 receptor] [GPIa]) (e.g., neonatal alloimmune 81109 $111.49 thrombocytopenia [NAIT], post-transfusion purpura), gene analysis, common variant (e.g., HPA-5a/b (K505E))

59

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Human Platelet Antigen 6 genotyping (HPA-6w), ITGB3 (integrin, beta 3 [platelet glycoprotein IIIa, 81110 $111.49 antigen CD61] [GPIIIa]) (e.g., neonatal alloimmune thrombocytopenia [NAIT], post-transfusion purpura), gene analysis, common variant, HPA-6a/b (R489Q) Human Platelet Antigen 9 genotyping (HPA-9w), ITGA2B (integrin, alpha 2b [platelet glycoprotein IIb of IIb/IIIa complex, antigen CD41] [GPIIb]) (e.g., 81111 $111.49 neonatal alloimmune thrombocytopenia [NAIT], post- transfusion purpura), gene analysis, common variant, HPA-9a/b (V837M) Human Platelet Antigen 15 genotyping (HPA-15), CD109 (CD109 molecule) (e.g., neonatal alloimmune 81112 $111.49 thrombocytopenia [NAIT], post-transfusion purpura), gene analysis, common variant, HPA-15a/b (S682Y) IDH1 (isocitrate dehydrogenase 1 [NADP+], soluble) 81120 $142.78 (e.g., glioma), common variants (e.g., R132H, R132C) IDH2 (isocitrate dehydrogenase 2 [NADP+], 81121 $218.55 mitochondrial) (e.g., glioma), common variants (e.g., R140W, R172M) DMD (dystrophin) (e.g., Duchenne/Becker muscular 81161 I.C. dystrophy) deletion analysis, and duplication analysis, if performed BRCA1, BRCA2 (breast cancer 1 and 2) (e.g., hereditary breast and ovarian cancer) gene analysis; 81162 $1,664.60 full sequence analysis and full duplication/deletion analysis BRCA1 (BRCA1, DNA repair associated), BRCA2 (BCA2, DNA repair associated) (e.g., hereditary breast 81163 $349.46 and ovarian cancer) gene analysis; full sequence analysis BRCA1 (BRCA1, DNA repair associated), BRCA2 (BCA2, DNA repair associated) (e.g., hereditary breast 81164 $436.24 and ovarian cancer) gene analysis; full duplication/deletion analysis (i.e., detection of large gene rearrangements) BRCA1 (BRCA1, DNA repair associated) (e.g., 81165 $211.23 hereditary breast and ovarian cancer) gene analysis; full sequence analysis BRCA1 (BRCA1, DNA repair associated) (e.g., hereditary breast and ovarian cancer) gene analysis; 81166 $225.02 full duplication/deletion analysis (i.e., detection of large gene rearrangements)

60

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description BRCA2 (BRCA2, DNA repair associated) (e.g., hereditary breast and ovarian cancer) gene analysis; 81167 $211.23 full duplication/deletion analysis (i.e., detection of large rearrangements) ABL1 (ABL proto-oncogene 1, non-receptor tyrosine kinase) (e.g., acquired imatinib tyrosine kinase 81170 $221.66 inhibitor resistance), gene analysis, variants in the kinase domain AFF2 (AF4/FMR2 family, member 2 [FMR2] (e.g., fragile X mental retardation 2 [FRAXE]) gene 81171 $102.30 analysis; evaluation to detect abnormal (e.g., expanded) alleles AFF2 (AF4/FMR2 family, member 2 [FMR2] (e.g., fragile X mental retardation 2 [FRAXE]) gene 81172 $205.22 analysis; characterization of alleles (e.g., expanded size and methylation status) AR (androgen receptor) (e.g., spinal and bulbar 81173 $225.02 muscular atrophy, Kennedy disease, X chromosome inactivation) gene analysis; full gene sequence AR (androgen receptor) (e.g., spinal and bulbar 81174 $138.29 muscular atrophy, Kennedy disease, X chromosome inactivation) gene analysis; known familial variant ASXL1 (additional sex combs like 1, transcriptional regulator) (e.g., myelodysplastic syndrome, 81175 $522.39 myeloproliferative neoplasms, chronic myelomonocytic leukemia), gene analysis; full gene sequence ASXL1 (additional sex combs like 1, transcriptional regulator) (e.g., myelodysplastic syndrome, 81176 $220.65 myeloproliferative neoplasms, chronic myelomonocytic leukemia), gene analysis; targeted sequence analysis (e.g., exon 12) ATN1 (atrophin 1) (e.g., dentatorural-pallidoluysian 81177 $102.30 atrophy) gene analysis; evaluation to detect abnormal (e.g., expanded) alleles ATXN1 (ataxin 1) (e.g., spinocerebellar ataxia) gene 81178 $102.30 analysis; evaluation to detect abnormal (e.g., expanded) alleles ATXN2 (ataxin 2) (e.g., spinocerebellar ataxia) gene 81179 $102.30 analysis; evaluation to detect abnormal (e.g., expanded) alleles ATXN3 (ataxin 3) (e.g., spinocerebellar ataxia, 81180 $102.30 Machado-Joseph disease) gene analysis; evaluation to detect abnormal (e.g., expanded) alleles

61

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description ATXN7 (ataxin 7) (e.g., spinocerebellar ataxia) gene 81181 $102.30 analysis; evaluation to detect abnormal (e.g., expanded) alleles ATXN8OS (ATXN8 opposite strand [non-protein 81182 $102.30 coding]) (e.g., spinocerebellar ataxia) gene analysis; evaluation to detect abnormal (e.g., expanded) alleles ATXN10 (ataxin 10) (e.g., spinocerebellar ataxia) gene 81183 $102.30 analysis; evaluation to detect abnormal (e.g., expanded) alleles CACNA1A (calcium voltage-gated channel subunit 81184 $102.30 alpha1 A) (e.g., spinocerebellar ataxia) gene analysis; evaluation to detect abnormal (e.g., expanded) alleles CACNA1A (calcium voltage-gated channel subunit 81185 $631.91 alpha1 A) (e.g., spinocerebellar ataxia) gene analysis; full gene sequence CACNA1A (calcium voltage-gated channel subunit 81186 $138.29 alpha1 A) (e.g., spinocerebellar ataxia) gene analysis; known familial variant CNBP (CCHC-type zinc finger nucleic acid binding protein) (e.g., myotonic dystrophy type 2) gene 81187 $102.30 analysis; evaluation to detect abnormal (e.g., expanded) alleles CSTB (cystatin B) (e.g., Unverricht-Lundborg disease) 81188 $102.30 gene analysis; evaluation to detect abnormal (e.g., expanded) alleles CSTB (cystatin B) (e.g., Unverricht-Lundborg disease) 81189 $205.22 gene analysis; full gene sequence CSTB (cystatin B) (e.g., Unverricht-Lundborg disease) 81190 $138.29 gene analysis; known familial variant ASPA (aspartoacylase) (e.g., Canavan disease) gene 81200 I.C. analysis; common variants (e.g., E285A, Y231X) APC (adenomatous polyposis coli) (e.g., familial 81201 I.C. adenomatosis polyposis [FAP], attenuated FAP) gene analysis; full gene sequence APC (adenomatous polyposis coli) (e.g., familial 81202 I.C. adenomatosis polyposis [FAP], attenuated FAP) gene analysis; known familial variants APC (adenomatous polyposis coli) (e.g., familial 81203 I.C. adenomatosis polyposis [FAP], attenuated FAP) gene analysis; duplication/deletion variants AR (androgen receptor) (e.g., spinal and bulbar muscular atrophy, Kennedy disease, X chromosome 81204 $102.30 inactivation) gene analysis; characterization of alleles (e.g., expanded size of methylation status)

62

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description BCKDHB (branched-chain keto acid dehydrogenase E1, beta polypeptide) (e.g., maple syrup urine disease) 81205 I.C. gene analysis; common variants (e.g., R183P, G278S, E422X) BCR/ABL1 (t(9;22)) (e.g., chronic myelogenous 81206 $149.56 leukemia) translocation analysis; major breakpoint, qualitative or quantitative BCR/ABL1 (t(9;22)) (e.g., chronic myelogenous 81207 $132.12 leukemia) translocation analysis; minor breakpoint, qualitative or quantitative BCR/ABL1 (t(9;22)) (e.g., chronic myelogenous 81208 $158.57 leukemia) translocation analysis; other breakpoint, qualitative or quantitative BLM (Bloom syndrome, RecQ helicase-like) (e.g., 81209 I.C. Bloom syndrome) gene analysis; 2281del6ins7 variant BRAF (B-Raf proto-oncogene, serine/threonine kinase) 81210 $129.60 (e.g., colon cancer, melanoma), gene analysis; V600 variant(s) BRCA1, BRCA2 (breast cancer 1 and 2) (e.g., 81212 $325.10 hereditary breast and ovarian cancer) gene analysis; 185delAG, 5385insC, 6174delT variants BRCA1 (breast cancer 1) (e.g., hereditary breast and 81215 $277.26 ovarian cancer) gene analysis; known familial variant BRCA2 (breast cancer 2) (e.g., hereditary breast and 81216 I.C. ovarian cancer) gene analysis; full sequence analysis BRCA2 (breast cancer 2) (e.g., hereditary breast and 81217 $277.26 ovarian cancer) gene analysis; known familial variant CEBPA (CCAAT/enhancer binding protein [C/EBP], 81218 $220.65 alpha) (e.g., acute myeloid leukemia), gene analysis; full gene sequence CALR (calreticulin) (e.g., myeloproliferative 81219 $110.95 disorders), gene analysis; common variants in exon 9 CFTR (cystic fibrosis transmembrane conductance 81220 $411.25 regulator) (e.g., cystic fibrosis) gene analysis; common variants (e.g., ACMG/ACOG guidelines) CFTR (cystic fibrosis transmembrane conductance 81221 I.C. regulator) (e.g., cystic fibrosis) gene analysis; known familial variants CFTR (cystic fibrosis transmembrane conductance 81222 I.C. regulator) (e.g., cystic fibrosis) gene analysis; duplication/deletion variants CFTR (cystic fibrosis transmembrane conductance 81223 I.C. regulator) (e.g., cystic fibrosis) gene analysis; full gene sequence

63

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description CFTR (cystic fibrosis transmembrane conductance 81224 I.C. regulator) (e.g., cystic fibrosis) gene analysis; intron 8 poly-T analysis (e.g., male infertility) CYP2C19 (cytochrome P450, family 2, subfamily C, 81225 $215.27 polypeptide 19) (e.g., drug metabolism), gene analysis; common variants (e.g., *2, *3, *4, *8, *17) CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (e.g., drug metabolism), gene analysis; 81226 $333.16 common variants (e.g., *2, *3, *4, *5, *6, *9, *10, *17, *19, *29, *35, *41, *1XN, *2XN, *4XN) CYP2C9 (cytochrome P450, family 2, subfamily C, 81227 $129.16 polypeptide 9) (e.g., drug metabolism), gene analysis; common variants (e.g., *2, *3, *5, *6) Cytogenomic constitutional (genome-wide) microarray analysis; interrogation of genomic regions for copy 81228 I.C. number variants (e.g., bacterial artificial chromosome [BAC] or oligo-based comparative genomic hybridization [CGH] microarray analysis) Cytogenomic constitutional (genome-wide) microarray analysis; interrogation of genomic regions for copy 81229 I.C. number and single nucleotide polymorphism (SNP) variants for chromosomal abnormalities CYP3A4 (cytochrome P450 family 3 subfamily A 81230 $129.16 member 4) (e.g., drug metabolism), gene analysis; common variant(s) (e.g., *2, *22) CYP3A5 (cytochrome P450 family 3 subfamily A 81231 $129.16 member 5) (e.g., drug metabolism), gene analysis; common variants (e.g., *2, *3, *4, *5, *6, *7) DPYD (dihydropyrimidine dehydrogenase) (e.g., 5- fluorouracil/5-FU and capecitabine drug metabolism), 81232 $129.16 gene analysis; common variant(s) (e.g., *2A, *4, *5, *6) BTK (Bruton’s tyrosine kinase) (e.g., chronic 81233 $130.97 lymphocytic leukemia) gene analysis; common variants (e.g., C481S, C481R, C481F) DMPK (DM1 protein kinase) (e.g., myotonic 81234 $102.30 dystrophy type 1) gene analysis; evaluation to detect abnormal (expanded) alleles EGFR (epidermal growth factor receptor) (e.g., non- small cell lung cancer) gene analysis; common variants 81235 $239.82 (e.g., exon 19 LREA deletion, L858R, T790M, G719A, G719S, L861Q)

64

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description EZH2 (enhancer of zeste 2 polycomb repressive complex 2 subunit) (e.g., diffuse large B-cell 81236 $211.23 lymphoma) gene analysis; common variant(s) (e.g., codon 646) EZH2 (enhancer of zeste 2 polycomb repressive complex 2 subunit) (e.g., myelodysplastic syndrome, 81237 $130.97 myeloproliferative neoplasms) gene analysis, common variant(s) (eg, codon 646) F9 (coagulation factor IX) (e.g., hemophilia B), full 81238 $443.32 gene sequence DMPK (DM1 protein kinase) (e.g., myotonic 81239 $205.22 dystrophy type 1) gene analysis; characterization of alleles (e.g., expanded size) F2 (prothrombin, coagulation factor II) (e.g., hereditary 81240 $48.54 hypercoagulability) gene analysis; 20210G>A variant F5 (coagulation factor V) (e.g., hereditary 81241 $55.74 hypercoagulability) gene analysis; Leiden variant FANCC (Fanconi anemia, complementation group C) 81242 I.C. (e.g., Fanconi anemia, type C) gene analysis; common variant (e.g., IVS4+4A>T) FMR1 (fragile X mental retardation 1) (e.g., fragile X 81243 I.C. mental retardation) gene analysis; evaluation to detect abnormal (e.g., expanded) alleles FMR1 (fragile X mental retardation 1) (e.g., fragile X 81244 I.C. mental retardation) gene analysis; characterization of alleles (e.g., expanded size and methylation status) FLT3 (fms-related tyrosine kinase 3) (e.g., acute 81245 $122.29 myeloid leukemia), gene analysis; internal tandem duplication (ITD) variants (i.e., exons 14, 15) FLT3 (fms-related tyrosine kinase 3) (e.g., acute 81246 $61.33 myeloid leukemia), gene analysis; tyrosine kinase domain (TKD) variants (e.g., D835, I836) G6PD (glucose-6-phosphate dehydrogenase) (e.g., 81247 $129.16 hemolytic anemia, jaundice), gene analysis; common variant(s) (e.g., A, A-) G6PD (glucose-6-phosphate dehydrogenase) (e.g., 81248 $277.26 hemolytic anemia, jaundice), gene analysis; known familial variant(s) G6PD (glucose-6-phosphate dehydrogenase) (e.g., 81249 $443.32 hemolytic anemia, jaundice), gene analysis; full gene sequence G6PC (glucose-6-phosphatase, catalytic subunit) (e.g., 81250 I.C. Glycogen storage disease, type 1a, von Gierke disease) gene analysis; common variants (e.g., R83C, Q347X)

65

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description GBA (glucosidase, beta, acid) (e.g., Gaucher disease) 81251 I.C. gene analysis; common variants (e.g., N370S, 84GG, L444P, IVS2+1G>A) GJB2 (gap junction protein, beta 2, 26kDa, connexin 81252 I.C. 26) (e.g., nonsyndromic hearing loss) gene analysis; full gene sequence GJB2 (gap junction protein, beta 2, 26kDa, connexin 81253 I.C. 26) (e.g., nonsyndromic hearing loss) gene analysis; known familial variants GJB6 (gap junction protein, beta 6, 30kDa, connexin 30) (e.g., nonsyndromic hearing loss) gene analysis; 81254 I.C. common variants (e.g., 309kb [del(GJB6-D13S1830)] and 232kb [del(GJB6-D13S1854)]) HEXA (hexosaminidase A [alpha polypeptide]) (e.g., 81255 I.C. Tay-Sachs disease) gene analysis; common variants (e.g., 1278insTATC, 1421+1G>C, G269S) HFE (hemochromatosis) (e.g., hereditary 81256 $59.62 hemochromatosis) gene analysis; common variants (e.g., C282Y, H63D) HBA1/HBA2 (alpha globin 1 and alpha globin 2) (e.g., alpha thalassemia, Hb Bart hydrops fetalis syndrome, HbH disease), gene analysis; common deletions or 81257 I.C. variant (e.g., Southeast Asian, Thai, Filipino, Mediterranean, alpha3.7, alpha4.2, alpha20.5, Constant Spring) HBA1/HBA2 (alpha globin 1 and alpha globin 2) (e.g., 81258 $277.26 alpha thalassemia, Hb Bart hydrops fetalis syndrome, HbH disease), gene analysis; known familial variant HBA1/HBA2 (alpha globin 1 and alpha globin 2) (e.g., 81259 $443.32 alpha thalassemia, Hb Bart hydrops fetalis syndrome, HbH disease), gene analysis; full gene sequence IKBKAP (inhibitor of kappa light polypeptide gene enhancer in B-cells, kinase complex-associated 81260 I.C. protein) (e.g., familial dysautonomia) gene analysis; common variants (e.g., 2507+6T>C, R696P) IGH@ (Immunoglobulin heavy chain locus) (e.g., leukemias and lymphomas, B-cell), gene 81261 $180.60 rearrangement analysis to detect abnormal clonal population(s); amplified methodology (e.g., polymerase chain reaction)

66

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description IGH@ (Immunoglobulin heavy chain locus) (e.g., leukemias and lymphomas, B-cell), gene 81262 $50.65 rearrangement analysis to detect abnormal clonal population(s); direct probe methodology (e.g., Southern blot) IGH@ (Immunoglobulin heavy chain locus) (e.g., 81263 $268.65 leukemia and lymphoma, B-cell), variable region somatic analysis IGK@ (Immunoglobulin kappa light chain locus) (e.g., leukemia and lymphoma, B-cell), gene rearrangement 81264 $136.21 analysis, evaluation to detect abnormal clonal population(s) Comparative analysis using Short Tandem Repeat (STR) markers; patient and comparative specimen (e.g., pre-transplant recipient and donor germline 81265 $196.16 testing, post-transplant non-hematopoietic recipient germline [e.g., buccal swab or other germline tissue sample] and donor testing, twin zygosity testing, or maternal cell contamination of fetal cells) Comparative analysis using Short Tandem Repeat (STR) markers; each additional specimen (e.g., additional cord blood donor, additional fetal samples 81266 I.C. from different cultures, or additional zygosity in multiple birth pregnancies) (List separately in addition to code for primary procedure) Chimerism (engraftment) analysis, post transplantation specimen (e.g., hematopoietic stem cell), includes 81267 $189.24 comparison to previously performed baseline analyses; without cell selection Chimerism (engraftment) analysis, post transplantation specimen (e.g., hematopoietic stem cell), includes 81268 $237.88 comparison to previously performed baseline analyses; with cell selection (e.g., CD3, CD33), each cell type HBA1/HBA2 (alpha globin 1 and alpha globin 2) (e.g., alpha thalassemia, Hb Bart hydrops fetalis syndrome, 81269 $149.54 HbH disease), gene analysis; duplication/deletion variants JAK2 (Janus kinase 2) (e.g., myeloproliferative 81270 $83.62 disorder) gene analysis; p.Val617Phe (V617F) variant HTT (huntingtin) (e.g., Huntington disease) gene 81271 $102.30 analysis; evaluation to detect abnormal (e.g., expanded) alleles

67

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description KIT (v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog) (e.g., gastrointestinal stromal 81272 $243.46 tumor [GIST], acute myeloid leukemia, melanoma), gene analysis; targeted sequence analysis (e.g., exons 8, 11, 13, 17, 18) KIT (v-kit Hardy-Zuckerman 4 feline sarcoma viral 81273 $92.26 oncogene homolog) (e.g., mastocytosis), gene analysis; D816 variant(s) HTT (huntingtin) (e.g., Huntington disease) gene 81274 $205.22 analysis; characterization of alleles (e.g., expanded) alleles KRAS (Kirsten rat sarcoma viral oncogene homolog) 81275 $142.78 (e.g., carcinoma) gene analysis; variants in exon 2 (e.g., codons 12 and 13) KRAS (Kirsten rat sarcoma viral oncogene homolog) 81276 $142.78 (e.g., carcinoma) gene analysis; additional variant(s) (e.g., codon 61, codon 146) Cytogenomic neoplasia (genome-wide) microarray analysis, interrogation of genomic regions for copy 81277 $857.12 number and loss-of-heterozygosity variants for chromosomal abnormalities IFNL3 (interferon, lambda 3) (e.g., drug response), 81283 $55.74 gene analysis; rs12979860 variant FXN (frataxin) (e.g., Friedreich ataxia) gene analysis; 81284 $102.30 evaluation to detect abnormal (expanded) alleles FXN (frataxin) (e.g., Friedreich ataxia) gene analysis; 81285 $205.22 characterization of alleles (e.g., expanded size) FXN (frataxin) (e.g., Friedreich ataxia) gene analysis; 81286 $205.22 full gene sequence MGMT (O-6-methylguanine-DNA methyltransferase) 81287 I.C. (e.g., glioblastoma multiforme), methylation analysis MLH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (e.g., hereditary non-polyposis colorectal 81288 $142.10 cancer, Lynch syndrome) gene analysis; promoter methylation analysis FXN (frataxin) (e.g., Friedreich ataxia) gene analysis; 81289 $138.29 known familial variant(s) MCOLN1 (mucolipin 1) (e.g., Mucolipidosis, type IV) 81290 I.C. gene analysis; common variants (e.g., IVS3-2A>G, del6.4kb) MTHFR (5,10-methylenetetrahydrofolate reductase) 81291 $48.28 (e.g., hereditary hypercoagulability) gene analysis; common variants (e.g., 677T, 1298C)

68

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description MLH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (e.g., hereditary non-polyposis colorectal 81292 $499.02 cancer, Lynch syndrome) gene analysis; full sequence analysis MLH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (e.g., hereditary non-polyposis colorectal 81293 $244.56 cancer, Lynch syndrome) gene analysis; known familial variants MLH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (e.g., hereditary non-polyposis colorectal 81294 $149.54 cancer, Lynch syndrome) gene analysis; duplication/deletion variants MSH2 (mutS homolog 2, colon cancer, nonpolyposis type 1) (e.g., hereditary non-polyposis colorectal 81295 $282.02 cancer, Lynch syndrome) gene analysis; full sequence analysis MSH2 (mutS homolog 2, colon cancer, nonpolyposis type 1) (e.g., hereditary non-polyposis colorectal 81296 $249.53 cancer, Lynch syndrome) gene analysis; known familial variants MSH2 (mutS homolog 2, colon cancer, nonpolyposis type 1) (e.g., hereditary non-polyposis colorectal 81297 $157.60 cancer, Lynch syndrome) gene analysis; duplication/deletion variants MSH6 (mutS homolog 6 [E. coli]) (e.g., hereditary 81298 $474.24 non-polyposis colorectal cancer, Lynch syndrome) gene analysis; full sequence analysis MSH6 (mutS homolog 6 [E. coli]) (e.g., hereditary 81299 $227.57 non-polyposis colorectal cancer, Lynch syndrome) gene analysis; known familial variants MSH6 (mutS homolog 6 [E. coli]) (e.g., hereditary 81300 $175.85 non-polyposis colorectal cancer, Lynch syndrome) gene analysis; duplication/deletion variants Microsatellite instability analysis (e.g., hereditary non- polyposis colorectal cancer, Lynch syndrome) of 81301 $264.13 markers for mismatch repair deficiency (e.g., BAT25, BAT26), includes comparison of neoplastic and normal tissue, if performed MECP2 (methyl CpG binding protein 2) (e.g., Rett 81302 I.C. syndrome) gene analysis; full sequence analysis MECP2 (methyl CpG binding protein 2) (e.g., Rett 81303 I.C. syndrome) gene analysis; known familial variant MECP2 (methyl CpG binding protein 2) (e.g., Rett 81304 I.C. syndrome) gene analysis; duplication/deletion variants

69

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description MYD88 (myeloid differentiation primary response 88) (e.g., Waldenstrom’s macroglobulinemia), 81305 $130.97 lymphoplasmacytic leukemia) gene analysis; p.Leu265Pro (L265P) variant NUTD15 (nudix hydrolase 15) (e.g., drug metabolism) 81306 $218.56 gene analysis; common variant(s) (e.g., *2, *3, *4, *5, *6) PALB2 (partner and localizer of BRCA2) (e.g., breast 81307 $209.02 and pancreatic cancer) gene analysis; full gene sequence PALB2 (partner and localizer of BRCA2) (e.g., breast 81308 $222.67 and pancreatic cancer) gene analysis; known familial variant PIK3CA (phosphatidylinositol-4, 5-biphosphate 3- kinase, catalytic subunit alpha) (e.g., colorectal and 81309 $203.07 breast cancer) gene analysis, targeted sequence analysis (e.g., exons 7, 9, 20) NPM1 (nucleophosmin) (e.g., acute myeloid leukemia) 81310 $182.14 gene analysis, exon 12 variants NRAS (neuroblastoma RAS viral [v-ras] oncogene homolog) (e.g., colorectal carcinoma), gene analysis; 81311 $218.55 variants in exon 2 (e.g., codons 12 and 13) and exon 3 (e.g., codon 61) PABPN1 (poly [A] binding proteinnuclear 1) (e.g., 81312 $102.30 oculopharyngeal muscular dystrophy) gene analysis, evaluation to detect abnormal (e.g., expanded) alleles PCA3/KLK3 (prostate cancer antigen 3 [non-protein 81313 $188.45 coding]/kallikrein-related peptidase 3 [prostate specific antigen]) ratio (e.g., prostate cancer) PDGFRA (platelet-derived growth factor receptor, alpha polypeptide) (e.g., gastrointestinal stromal tumor 81314 $243.46 [GIST]), gene analysis; targeted sequence analysis (e.g., exons 12, 18) PML/RARalpha, (t(15;17)), (promyelocytic leukemia/retinoic acid receptor alpha) (e.g., 81315 $189.10 promyelocytic leukemia) translocation analysis; common breakpoints (e.g., intron 3 and intron 6), qualitative or quantitative PML/RARalpha, (t(15;17)), (promyelocytic leukemia/retinoic acid receptor alpha) (e.g., 81316 $189.10 promyelocytic leukemia) translocation analysis; single breakpoint (e.g., intron 3, intron 6 or exon 6), qualitative or quantitative

70

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description PMS2 (postmeiotic segregation increased 2 [S. cerevisiae]) (e.g., hereditary non-polyposis colorectal 81317 $522.39 cancer, Lynch syndrome) gene analysis; full sequence analysis PMS2 (postmeiotic segregation increased 2 [S. cerevisiae]) (e.g., hereditary non-polyposis colorectal 81318 $244.56 cancer, Lynch syndrome) gene analysis; known familial variants PMS2 (postmeiotic segregation increased 2 [S. cerevisiae]) (e.g., hereditary non-polyposis colorectal 81319 $150.36 cancer, Lynch syndrome) gene analysis; duplication/deletion variants PLCG2 (phospholipase C gamma 2) (e.g., chronic 81320 $217.56 lymphocytic leukemia) gene analysis; common variants (e.g., R665W, S707F, L845F) PTEN (phosphatase and tensin homolog) (e.g., 81321 $443.32 Cowden syndrome, PTEN hamartoma tumor syndrome) gene analysis; full sequence analysis PTEN (phosphatase and tensin homolog) (e.g., 81322 $39.05 Cowden syndrome, PTEN hamartoma tumor syndrome) gene analysis; known familial variant PTEN (phosphatase and tensin homolog) (e.g., 81323 $221.66 Cowden syndrome, PTEN hamartoma tumor syndrome) gene analysis; duplication/deletion variant PMP22 (peripheral myelin protein 22) (e.g., Charcot- Marie-Tooth, hereditary neuropathy with liability to 81324 I.C. pressure palsies) gene analysis; duplication/deletion analysis PMP22 (peripheral myelin protein 22) (e.g., Charcot- 81325 I.C. Marie-Tooth, hereditary neuropathy with liability to pressure palsies) gene analysis; full sequence analysis PMP22 (peripheral myelin protein 22) (e.g., Charcot- 81326 I.C. Marie-Tooth, hereditary neuropathy with liability to pressure palsies) gene analysis; known familial variant SEPT9 (Septin9) (e.g., colorectal cancer) methylation 81327 I.C. analysis SLCO1B1 (solute carrier organic anion transporter 81328 $129.16 family, member 1B1) (e.g., adverse drug reaction), gene analysis; common variant(s) (e.g., *5) SMN1 (survival of motor neon 1, telemetric) (e.g., spinal muscular atrophy) gene analysis; 81329 $102.30 dosage/deletion analysis (e.g., carrier testing), includes SMN2 (survival of motor neuron 2, centromeric) analysis, if performed

71

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description SMPD1(sphingomyelin phosphodiesterase 1, acid lysosomal) (e.g., Niemann-Pick disease, Type A) gene 81330 I.C. analysis; common variants (e.g., R496L, L302P, fsP330) SNRPN/UBE3A (small nuclear ribonucleoprotein polypeptide N and ubiquitin protein ligase E3A) (e.g., 81331 I.C. Prader-Willi syndrome and/or Angelman syndrome), methylation analysis SERPINA1 (serpin peptidase inhibitor, clade A, alpha- 1 antiproteinase, antitrypsin, member 1) (e.g., alpha-1- 81332 $39.82 antitrypsin deficiency), gene analysis; common variants (e.g., *S and *Z) TGFBI (transforming growth factor beta-induced) (e.g., corneal dystrophy) gene analysis; common 81333 $102.30 variants (e.g., R124H, R124C, R124L, R555W, R555Q) RUNX1 (runt related transcription factor 1) (e.g., acute myeloid leukemia, familial platelet disorder with 81334 $243.46 associated myeloid malignancy), gene analysis; targeted sequence analysis (e.g., exons 3-8) TPMT (thiopurine S-methyltransferase) (e.g., drug 81335 $129.16 metabolism), gene analysis; common variants (e.g., *2, *3) SMN1 (survival of motor neon 1, telemetric) (e.g., 81336 $225.02 spinal muscular atrophy) gene analysis; full gene analysis SMN1 (survival of motor neon 1, telemetric) (e.g., 81337 $138.29 spinal muscular atrophy) gene analysis; known familial variant(s) TRB@ (T cell antigen receptor, beta) (e.g., leukemia and lymphoma), gene rearrangement analysis to detect 81340 $190.57 abnormal clonal population(s); using amplification methodology (e.g., polymerase chain reaction) TRB@ (T cell antigen receptor, beta) (e.g., leukemia and lymphoma), gene rearrangement analysis to detect 81341 $45.23 abnormal clonal population(s); using direct probe methodology (e.g., Southern blot) TRG@ (T cell antigen receptor, gamma) (e.g., leukemia and lymphoma), gene rearrangement 81342 $183.80 analysis; evaluation to detect abnormal clonal population(s) PPP2R2B (protein phosphatase 2 regulatory subunit 81343 $102.30 Bbeta) (e.g., spinocerebellar ataxia) gene analysis; evaluation to detect abnormal (e.g., expanded) alleles

72

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description TBP (TATA box binding protein) (spinoceenellar 81344 $102.30 ataxia) gene analysis; evaluation to detect abnormal (e.g., expanded) alleles TERT (telomerase reverse transcriptase) (e.g., thyroid 81345 $138.29 carcinoma, glioblastoma multiforme) gene analysis; targeted sequence analysis (e.g., promoter region) TYMS (thymidylate synthetase) (e.g., 5-fluorouracil/5- 81346 $129.16 FU drug metabolism), gene analysis; common variant(s) (e.g., tandem repeat variant) UGT1A1 (UDP glucuronosyltransferase 1 family, 81350 I.C. polypeptide A1) (e.g., irinotecan metabolism), gene analysis; common variants (e.g., *28, *36, *37) VKORC1 (vitamin K epoxide reductase complex, 81355 I.C. subunit 1) (e.g., warfarin metabolism), gene analysis; common variant(s) (e.g., -1639G>A, c.173+1000C>T) HBB (hemoglobin, subunit beta) (e.g., sickle cell 81361 $129.16 anemia, beta thalassemia, hemoglobinopathy); common variant(s) (e.g., HbS, HbC, HbE) HBB (hemoglobin, subunit beta) (e.g., sickle cell 81362 $277.26 anemia, beta thalassemia, hemoglobinopathy); known familial variant(s) HBB (hemoglobin, subunit beta) (e.g., sickle cell 81363 $149.54 anemia, beta thalassemia, hemoglobinopathy); duplication/deletion variant(s) HBB (hemoglobin, subunit beta) (e.g., sickle cell 81364 $239.82 anemia, beta thalassemia, hemoglobinopathy); full gene sequence HLA Class I and II typing, low resolution (e.g., antigen 81370 $366.81 equivalents); HLA-A, -B, -C, -DRB1/3/4/5, and - DQB1 HLA Class I and II typing, low resolution (e.g., antigen 81371 $298.88 equivalents); HLA-A, -B, and -DRB1 (e.g., verification typing) HLA Class I typing, low resolution (e.g., antigen 81372 $298.20 equivalents); complete (i.e., HLA-A, -B, and -C) HLA Class I typing, low resolution (e.g., antigen 81373 $101.58 equivalents); one locus (e.g., HLA-A, -B, or -C), each HLA Class I typing, low resolution (e.g., antigen 81374 $66.36 equivalents); one antigen equivalent (e.g., B*27), each HLA Class II typing, low resolution (e.g., antigen 81375 $201.35 equivalents); HLA-DRB1/3/4/5 and -DQB1 HLA Class II typing, low resolution (e.g., antigen 81376 $111.49 equivalents); one locus (e.g., HLA-DRB1, -DRB3/4/5, -DQB1, -DQA1, -DPB1, or -DPA1), each

73

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description HLA Class II typing, low resolution (e.g., antigen 81377 $83.75 equivalents); one antigen equivalent, each HLA Class I and II typing, high resolution (i.e., alleles 81378 $315.22 or allele groups), HLA-A, -B, -C, and -DRB1 HLA Class I typing, high resolution (i.e., alleles or 81379 $305.92 allele groups); complete (i.e., HLA-A, -B, and -C) HLA Class I typing, high resolution (i.e., alleles or 81380 $161.68 allele groups); one locus (e.g., HLA-A, -B, or -C), each HLA Class I typing, high resolution (i.e., alleles or 81381 $125.53 allele groups); one allele or allele group (e.g., B*57:01P), each HLA Class II typing, high resolution (i.e., alleles or 81382 $112.82 allele groups); one locus (e.g., HLA-DRB1, - DRB3/4/5, -DQB1, -DQA1, -DPB1, or -DPA1), each HLA Class II typing, high resolution (i.e., alleles or 81383 $99.55 allele groups); one allele or allele group (e.g., HLA- DQB1*06:02P), each 81400 I.C. Molecular Pathology Procedure Level 1 81401 I.C. Molecular Pathology Procedure Level 2 81402 I.C. Molecular Pathology Procedure Level 3 81403 I.C. Molecular Pathology Procedure Level 4 81404 I.C. Molecular Pathology Procedure Level 5 81405 I.C. Molecular Pathology Procedure Level 6 81406 I.C. Molecular Pathology Procedure Level 7 81407 I.C. Molecular Pathology Procedure Level 8 81408 I.C. Molecular Pathology Procedure Level 9 Aortic dysfunction or dilation (e.g., Marfan syndrome, Loeys Dietz syndrome, Ehler Danlos syndrome type IV, arterial tortuosity syndrome); genomic sequence 81410 $372.38 analysis panel, must include sequencing of at least 9 , including FBN1, TGFBR1, TGFBR2, COL3A1, MYH11, ACTA2, SLC2A10, SMAD3, and MYLK Aortic dysfunction or dilation (e.g., Marfan syndrome, Loeys Dietz syndrome, Ehler Danlos syndrome type 81411 $997.60 IV, arterial tortuosity syndrome); duplication/deletion analysis panel, must include analyses for TGFBR1, TGFBR2, MYH11, and COL3A1

74

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Ashkenazi Jewish associated disorders (e.g., Bloom syndrome, Canavan disease, cystic fibrosis, familial dysautonomia, Fanconi anemia group C, Gaucher 81412 $1,809.14 disease, Tay-Sachs disease); genomic sequence analysis panel, must include sequencing of at least 9 genes, including ASPA, BLM, CFTR, FANCC, GBA, HEXA, IKBKAP, MCOLN1, and SMPD1 Cardiac ion channelopathies (e.g., Brugada syndrome, long QT syndrome, short QT syndrome, catecholaminergic polymorphic ventricular 81413 $533.53 tachycardia); genomic sequence analysis panel, must include sequencing of at least 10 genes, including ANK2, CASQ2, CAV3, KCNE1, KCNE2, KCNH2, KCNJ2, KCNQ1, RYR2, and SCN5A Cardiac ion channelopathies (e.g., Brugada syndrome, long QT syndrome, short QT syndrome, catecholaminergic polymorphic ventricular 81414 $533.53 tachycardia); duplication/deletion gene analysis panel, must include analysis of at least 2 genes, including KCNH2 and KCNQ1 Exome (e.g., unexplained constitutional or heritable 81415 $3,531.74 disorder or syndrome); sequence analysis Exome (e.g., unexplained constitutional or heritable disorder or syndrome); sequence analysis, each 81416 $8,866.30 comparator exome (e.g., parents, siblings) (List separately in addition to code for primary procedure) Exome (e.g., unexplained constitutional or heritable disorder or syndrome); re-evaluation of previously 81417 $236.43 obtained exome sequence (e.g., updated knowledge or unrelated condition/syndrome) Fetal chromosomal aneuploidy (e.g., trisomy 21, monosomy X) genomic sequence analysis panel, 81420 $560.83 circulating cell-free fetal DNA in maternal blood, must include analysis of 13, 18, and 21 Fetal chromosomal microdeletion(s) genomic sequence analysis (e.g., DiGeorge syndrome, Cri-du-chat 81422 $560.83 syndrome), circulating cell-free fetal DNA in maternal blood Genome (e.g., unexplained constitutional or heritable 81425 I.C disorder or syndrome); sequence analysis Genome (e.g., unexplained constitutional or heritable disorder or syndrome); sequence analysis, each 81426 I.C. comparator genome (e.g., parents, siblings) (List separately in addition to code for primary procedure)

75

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Genome (e.g., unexplained constitutional or heritable disorder or syndrome); re-evaluation of previously 81427 I.C. obtained genome sequence (e.g., updated knowledge or unrelated condition/syndrome) Hearing loss (e.g., nonsyndromic hearing loss, Usher syndrome, Pendred syndrome); genomic sequence analysis panel, must include sequencing of at least 60 81430 $1,200.64 genes, including CDH23, CLRN1, GJB2, GPR98, MTRNR1, MYO7A, MYO15A, PCDH15, OTOF, SLC26A4, TMC1, TMPRSS3, USH1C, USH1G, USH2A, and WFS1 Hearing loss (e.g., nonsyndromic hearing loss, Usher syndrome, Pendred syndrome); duplication/deletion 81431 $502.11 analysis panel, must include copy number analyses for STRC and DFNB1 deletions in GJB2 and GJB6 genes Hereditary breast cancer-related disorders (e.g., hereditary breast cancer, hereditary ovarian cancer, hereditary endometrial cancer); genomic sequence 81432 $619.41 analysis panel, must include sequencing of at least 10 genes, always including BRCA1, BRCA2, CDH1, MLH1, MSH2, MSH6, PALB2, PTEN, STK11, and TP53 Hereditary breast cancer-related disorders (e.g., hereditary breast cancer, hereditary ovarian cancer, 81433 $400.38 hereditary endometrial cancer); duplication/deletion analysis panel, must include analyses for BRCA1, BRCA2, MLH1, MSH2, and STK11 Hereditary retinal disorders (e.g., , Leber congenital amaurosis, cone-rod dystrophy); genomic sequence analysis panel, must include 81434 $441.77 sequencing of at least 15 genes, including ABCA4, CNGA1, CRB1, EYS, PDE6A, PDE6B, PRPF31, PRPH2, RDH12, RHO, RP1, RP2, RPE65, RPGR, and USH2A Hereditary colon cancer disorders (e.g., Lynch syndrome, PTEN hamartoma syndrome, Cowden syndrome, familial adenomatosis polyposis); genomic 81435 $533.53 sequence analysis panel, must include sequencing of at least 10 genes, including APC, BMPR1A, CDH1, MLH1, MSH2, MSH6, MUTYH, PTEN, SMAD4, and STK11

76

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Hereditary colon cancer disorders (e.g., Lynch syndrome, PTEN hamartoma syndrome, Cowden syndrome, familial adenomatosis polyposis); 81436 $533.53 duplication/deletion analysis panel, must include analysis of at least 5 genes, including MLH1, MSH2, EPCAM, SMAD4, and STK11 Hereditary neuroendocrine tumor disorders (e.g., medullary thyroid carcinoma, parathyroid carcinoma, malignant pheochromocytoma or paraganglioma); 81437 $400.38 genomic sequence analysis panel, must include sequencing of at least 6 genes, including MAX, SDHB, SDHC, SDHD, TMEM127, and VHL Hereditary neuroendocrine tumor disorders (e.g., medullary thyroid carcinoma, parathyroid carcinoma, 81438 $400.38 malignant pheochromocytoma or paraganglioma); duplication/deletion analysis panel, must include analyses for SDHB, SDHC, SDHD, and VHL Hereditary cardiomyopathy (e.g., hypertrophic cardiomyopathy, dilated cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy); 81439 $533.53 genomic sequence analysis panel, must include sequencing of at least 5 cardiomyopathy-related genes (e.g., DSG2, MYBPC3, MYH7, PKP2, TTN) Nuclear encoded mitochondrial genes (e.g., neurologic or myopathic phenotypes); genomic sequence panel, must include analysis of at least 100 genes, including 81440 $2,455.97 BCS1L, C10orf2, COQ2, COX10, DGUOK, MPV17, OPA1, PDSS2, POLG, POLG2, RRM2B, SCO1, SCO2, SLC25A4, SUCLA2, SUCLG1, TAZ, TK2, and TYMP Noonan spectrum disorders (e.g., Noonan syndrome, cardio-facio-cutaneous syndrome, Costello syndrome, LEOPARD syndrome, Noonan-like syndrome); 81442 $1,583.82 genomic sequence analysis panel, must include sequencing of at least 12 genes, including BRAF, CBL, HRAS, KRAS, MAP2K1, MAP2K2, NRAS, PTPN11, RAF1, RIT1, SHOC2, and SOS1

77

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Genetic testing for severe inherited conditions (e.g., cystic fibrosis, Ashkenazi Jewish associated disorders [e.g., Bloom syndrome, Canavan disease, Fanconi anemia type C, mucolipidosis yipe VI, Gaucher disease, Tay-Sachs disease], beta humoglobinopathies, 81443 $1828.34 phenylketonuria, galactosemia); genomic sequence analysis panel, must include sequencing of at least 15 genes (e.g., SCADM, ARSA, ASPA, ATP7B, BCKDHA, BCDHB, BLM, CFTR, DHCR7, FANCC, G6PC, GAA, GALT, GBA, GBE1, HBB, HEXA, IBKAP, MCOLN1, PAH) Targeted genomic sequence analysis panel, solid organ neoplasm, DNA analysis, and RNA analysis when performed, 5-50 genes (e.g., ALK, BRAF, CDKN2A, 81445 $441.77 EGFR, ERBB2, KIT, KRAS, NRAS, MET, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, if performed Hereditary peripheral neuropathies (e.g., Charcot- Marie-Tooth, spastic paraplegia); genomic sequence analysis panel, must include sequencing of at least 5 81448 $533.53 peripheral neuropathy-related genes (e.g., BSCL2, GJB1, MFN2, MPZ, REEP1, SPAST, SPG11, SPTLC1) Targeted genomic sequence analysis panel, hematolymphoid neoplasm or disorder, DNA analysis, and RNA analysis when performed, 5-50 genes (e.g., BRAF, CEBPA, DNMT3A, EZH2, FLT3, IDH1, 81450 $561.19 IDH2, JAK2, KRAS, KIT, MLL, NRAS, NPM1, NOTCH1), interrogation for sequence variants, and copy number variants or rearrangements, or isoform expression or mRNA expression levels, if performed Targeted genomic sequence analysis panel, solid organ or hematolymphoid neoplasm, DNA analysis, and RNA analysis when performed, 51 or greater genes (e.g., ALK, BRAF, CDKN2A, CEBPA, DNMT3A, 81455 $2,157.17 EGFR, ERBB2, EZH2, FLT3, IDH1, IDH2, JAK2, KIT, KRAS, MLL, NPM1, NRAS, MET, NOTCH1, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, if performed

78

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Whole mitochondrial genome (e.g., Leigh syndrome, mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes [MELAS], myoclonic epilepsy with ragged-red fibers [MERFF], neuropathy, ataxia, 81460 $950.91 and retinitis pigmentosa [NARP], Leber hereditary optic neuropathy [LHON]); genomic sequence, must include sequence analysis of entire mitochondrial genome with heteroplasmy detection Whole mitochondrial genome large deletion analysis panel (e.g., Kearns-Sayre syndrome, chronic 81465 $691.57 progressive external ophthalmoplegia), including heteroplasmy detection, if performed X-linked intellectual disability (XLID) (e.g., syndromic and non-syndromic XLID); genomic sequence analysis panel, must include sequencing of at 81470 I.C. least 60 genes, including ARX, ATRX, CDKL5, FGD1, FMR1, HUWE1, IL1RAPL, KDM5C, L1CAM, MECP2, MED12, MID1, OCRL, RPS6KA3, and SLC16A2 X-linked intellectual disability (XLID) (e.g., syndromic and non-syndromic XLID); duplication/deletion gene analysis, must include 81471 I.C. analysis of at least 60 genes, including ARX, ATRX, CDKL5, FGD1, FMR1, HUWE1, IL1RAPL, KDM5C, L1CAM, MECP2, MED12, MID1, OCRL, RPS6KA3, and SLC16A2 81479 I.C. Unlisted molecular pathology procedure Autoimmune (rheumatoid arthritis), analysis of 12 biomarkers using immunoassays, utilizing serum, 81490 $621.12 prognostic algorithm reported as a disease activity score Coronary artery disease, mRNA, gene expression profiling by real-time RT-PCR of 23 genes, utilizing 81493 $775.80 whole peripheral blood, algorithm reported as a risk score Oncology (ovarian), biochemical assays of two 81500 I.C. proteins (CA-125 and HE4), utilizing serum, with menopausal status, algorithm reported as a risk score Oncology (ovarian), biochemical assays of five proteins (CA-125, apolipoprotein A1, beta-2 81503 I.C. microglobulin, transferrin, and pre-albumin), utilizing serum, algorithm reported as a risk score

79

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Endocrinology (type 2 diabetes), biochemical assays of seven analytes (glucose, HbA1c, insulin, hs-CRP, 81506 I.C. adiponectin, ferritin, interleukin 2-receptor alpha), utilizing serum or plasma, algorithm reporting a risk score Fetal congenital abnormalities, biochemical assays of 81508 I.C. two proteins (PAPP-A, hCG [any form]), utilizing maternal serum, algorithm reported as a risk score Fetal congenital abnormalities, biochemical assays of three proteins (PAPP-A, hCG [any form], DIA), 81509 I.C. utilizing maternal serum, algorithm reported as a risk score Fetal congenital abnormalities, biochemical assays of 81510 I.C. three analytes (AFP, uE3, hCG [any form]), utilizing maternal serum, algorithm reported as a risk score Fetal congenital abnormalities, biochemical assays of four analytes (AFP, uE3, hCG [any form], DIA) 81511 I.C. utilizing maternal serum, algorithm reported as a risk score (may include additional results from previous biochemical testing) Fetal congenital abnormalities, biochemical assays of five analytes (AFP, uE3, total hCG, hyperglycosylated 81512 I.C. hCG, DIA) utilizing maternal serum, algorithm reported as a risk score Oncology (breast), mRNA, gene expression profiling by real-time RT-PCR of 11 genes (7 content and 4 housekeeping), utilizing formalin-fixed paraffin- 81518 $2891.97 embedded tissue, algorithms reported as percentage risk for metastatic recurrence and likelihood of benefit from extended endocrine therapy Oncology (breast), mRNA, gene expression profiling by real-time RT-PCR of 21 genes, utilizing formalin- 81519 $2,861.60 fixed paraffin embedded tissue, algorithm reported as recurrence score Oncology (breast), mRNA gene expression profiling by hybrid capture of 58 genes (50 content and 8 81520 $2,289.74 housekeeping), utilizing formalin-fixed paraffin- embedded tissue, algorithm reported as a recurrence risk score Oncology (breast), mRNA, microarray gene expression profiling of 70 content genes and 465 housekeeping 81521 $2,861.60 genes, utilizing fresh frozen or formalin-fixed paraffin- embedded tissue, algorithm reported as index related to risk of distant metastasis

80

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Oncology (breast), mRNA, gene expression profiling by RT-PCR of 12 genes (8 content and 4 81522 $2,861.76 housekeeping), utilizing formalin-fixed paraffin- embedded tissue, algorithm reported as recurrence risk score Oncology (colon), mRNA, gene expression profiling by real-time RT-PCR of 12 genes (7 content and 5 81525 $2,302.28 housekeeping), utilizing formalin-fixed paraffin- embedded tissue, algorithm reported as a recurrence score Oncology (colorectal) screening, quantitative real-time target and signal amplification of 10 DNA markers 81528 $375.98 (KRAS , promoter methylation of NDRG4 and BMP3) and fecal hemoglobin, utilizing stool, algorithm reported as a positive or negative result Oncology (gynecologic), live tumor cell culture and chemotherapeutic response by DAPI stain and 81535 $428.14 morphology, predictive algorithm reported as a drug response score; first single drug or drug combination Oncology (gynecologic), live tumor cell culture and chemotherapeutic response by DAPI stain and morphology, predictive algorithm reported as a drug 81536 $131.19 response score; each additional single drug or drug combination (List separately in addition to code for primary procedure) Oncology (lung), mass spectrometric 8-protein signature, including amyloid A, utilizing serum, 81538 $2,121.26 prognostic and predictive algorithm reported as good versus poor overall survival Oncology (high-grade prostate cancer), biochemical assay of four proteins (Total PSA, Free PSA, Intact 81539 $561.53 PSA, and human kallikrein-2 [hK2]), utilizing plasma or serum, prognostic algorithm reported as a probability score Oncology (tumor of unknown origin), mRNA, gene expression profiling by real-time RT-PCR of 92 genes (87 content and 5 housekeeping) to classify tumor into 81540 $2,770.72 main cancer type and subtype, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a probability of a predicted main cancer type and subtype

81

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Oncology (prostate), mRNA gene expression profiling by real-time RT-PCR of 46 genes (31 content and 15 81541 $2,861.60 housekeeping), utilizing formalin-fixed paraffin- embedded tissue, algorithm reported as a disease- specific mortality risk score Oncology (prostate), mRNA, microarray gene expression profiling of 22 content genes, utilizing 81542 I.C. formalin-fixed paraffin-embedded tissue, algorithm reported as metastasis risk score Oncology (thyroid), gene expression analysis of 142 81545 $2,659.89 genes, utilizing fine needle aspirate, algorithm reported as a categorical result (e.g., benign or suspicious) Oncology (prostate), promoter methylation profiling by real-time PCR of 3 genes (GSTP1, APC, RASSF1), 81551 I.C. utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a likelihood of prostate cancer detection on repeat biopsy Oncology (uveal melanoma), mRNA, gene expression profiling by real-time RT-PCR of 15 genes (12 content 81552 I.C. and 3 housekeeping), utilizing fine needle aspirate or formalin-fixed paraffin-embedded tissue, algorithm reported as risk of metastasis Cardiology (heart transplant), mRNA, gene expression profiling by real-time quantitative PCR of 20 genes (11 81595 $2,393.90 content and 9 housekeeping), utilizing subfraction of peripheral blood, algorithm reported as a rejection risk score Infectious disease, chronic hepatitis C virus (HCV) infection, six biochemical assays (ALT, A2- macroglobulin, apolipoprotein A-1, totalo bilirubin, 81596 $53.90 GGT, and haptoglobin) utilizing serum, prognostic algorithm reported as scores for fibrosis and necroinflammatory activity in liver 81599 I.C. Unlisted multianalyte assay with algorithmic analysis Semen analysis; presence and/or motility of sperm G0027 $5.93 excluding Huhner Prostate cancer screening; prostate specific antigen test G0103 $16.78 (PSA) Screening cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, G0123 $18.48 automated thin layer preparation, screening by cytotechnologist under physician supervision

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Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Screening cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, G0143 $19.99 automated thin layer preparation, with manual screening and rescreening by cytotechnologist under physician supervision Screening cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, G0144 $32.49 automated thin layer preparation, with screening by automated system, under physician supervision Screening cytopathology, cervical or vaginal (any reporting system), collected in preservative fluid, G0145 $24.17 automated thin layer preparation, with screening by automated system and manual rescreening under physician supervision Screening cytopathology smears, cervical or vaginal, G0147 $10.82 performed by automated system under physician supervision Screening cytopathology smears, cervical or vaginal, G0148 $23.60 performed by automated system with manual rescreening Complete CBC, automated (HgB, HCT, RBC, WBC, G0306 $7.09 without platelet count) and automated WBC differential count Complete (CBC), automated (HgB, Hct, RBC, WBC; G0307 $5.90 without platelet count) Colorectal cancer screening; fecal occult blood test, G0328 $14.51 immunoassay, 1-3 simultaneous determinations Infectious agent antibody detection by enzyme G0432 $14.46 immunoassay (EIA) technique, HIV-1 and/or HIV-2, screening Infectious agent antibody detection by enzyme-linked G0433 $13.51 immunosorbent assay (ELISA) technique, HIV-1 and/or HIV-2, screening Infectious agent antigen detection by rapid antibody G0435 $10.94 test of oral mucosa transudate, HIV-1 or HIV-2, screening

83

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Drug test(s), definitive, utilizing (1) drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including, but not limited to, GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem and excluding immunoassays (e.g., IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (e.g., alcohol dehydrogenase)), G0480 $59.69 (2) stable isotope or other universally recognized internal standards in all samples (e.g., to control for matrix effects, interferences and variations in signal strength), and (3) method or drug-specific calibration and matrix-matched quality control material (e.g., to control for instrument variations and mass spectral drift); qualitative or quantitative, all sources, includes specimen validity testing, per day; 1-7 drug class(es), including metabolite(s) if performed Drug test(s), definitive, utilizing (1) drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including, but not limited to, GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem and excluding immunoassays (e.g., IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (e.g., alcohol dehydrogenase)), G0481 $91.84 (2) stable isotope or other universally recognized internal standards in all samples (e.g., to control for matrix effects, interferences and variations in signal strength), and (3) method or drug-specific calibration and matrix-matched quality control material (e.g., to control for instrument variations and mass spectral drift); qualitative or quantitative, all sources, includes specimen validity testing, per day; 8-14 drug class(es), including metabolite(s) if performed

84

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Drug test(s), definitive, utilizing (1) drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including, but not limited to, GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem and excluding immunoassays (e.g., IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (e.g., alcohol dehydrogenase)), G0482 $123.97 (2) stable isotope or other universally recognized internal standards in all samples (e.g., to control for matrix effects, interferences and variations in signal strength), and (3) method or drug-specific calibration and matrix-matched quality control material (e.g., to control for instrument variations and mass spectral drift); qualitative or quantitative, all sources, includes specimen validity testing, per day; 15-21 drug class(es), including metabolite(s) if performed Drug test(s), definitive, utilizing (1) drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including, but not limited to, GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem and excluding immunoassays (e.g., IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (e.g., alcohol dehydrogenase)), G0483 $160.71 (2) stable isotope or other universally recognized internal standards in all samples (e.g., to control for matrix effects, interferences and variations in signal strength), and (3) method or drug-specific calibration and matrix-matched quality control material (e.g., to control for instrument variations and mass spectral drift); qualitative or quantitative, all sources, includes specimen validity testing, per day; 22 or more drug class(es), including metabolite(s) if performed Specimen collection for severe acute respiratory G2023 $23.46 syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), any specimen source

85

Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Specimen collection for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), any specimen source. [Used when provider 1) has a qualified ordering clinician present at the specimen collection site available to G2023 CG $44.27 order medically necessary COVID-19 diagnostic tests; and 2) ensures the test results are provided to the patient (along with any initial follow-up counseling, as appropriate), either directly or through the patient’s ordering clinician.] Specimen collection for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus G2024 $25.46 disease [COVID-19]), from an individual in a skilled nursing facility or by a laboratory on behalf of a home health agency, any specimen source Specimen collection for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), from an individual in a skilled nursing facility or by a laboratory on behalf of a home health agency, any specimen source. [Used when provider 1) has a qualified ordering clinician present at G2024 CG $46.27 the specimen collection site available to order medically necessary COVID-19 diagnostic tests; and 2) ensures the test results are provided to the patient (along with any initial follow-up counseling, as appropriate), either directly or through the patient’s ordering clinician.] Warfarin responsiveness testing by genetic technique G9143 $110.11 using any method, any number of specimen(s) P2028 I.C. Cephalin floculation, blood P2029 I.C. Congo red, blood P2031 I.C. Hair analysis (excluding arsenic) P2033 I.C. Thymol turbidity, blood Mucoprotein, blood (seromucoid) (medical necessity P2038 $4.51 procedure) Travel allowance, one way in connection with medically necessary laboratory specimen collection P9604 $4.59 drawn from homebound or nursing homebound patient; prorated trip charge Catheterization for collection of specimen, single P9612 $2.22 patient, all places of service Catheterization for collection of specimen(s) (multiple P9615 $2.22 patients)

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Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

Code Rate Description Wet mounts, including preparations of vaginal, Q0111 $10.82 cervical or skin specimens Q0112 $4.31 All potassium hydroxide (KOH) preparations Q0113 $3.89 Pinworm examinations Q0114 $7.20 Fern test Postcoital direct, qualitative examinations of vaginal or Q0115 $18.47 cervical mucous 2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV U0002 $51.31 (COVID-19) using any technique, multiple types or subtypes (includes all targets) Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), U0003 $75.00 amplified probe technique, making use of high throughput technologies as described by CMS-2020- 01-R 2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique, multiple types or U0004 $75.00 subtypes (includes all targets), non-CDC, making use of high throughput technologies as described by CMS- 2020-01-R Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique, CDC or non-CDC, making use of high throughput technologies, completed within U0005 $25.00 2 calendar days from date and time of specimen collection. In addition, to be eligible to bill this code, laboratory must complete the majority of their COVID- 19 diagnostic tests that use high throughput technology in two calendar days or less for all of their patients in the previous month.

320.06: Filing and Reporting Requirements

(1) Required Reports. Reporting requirements are governed by 957 CMR 6.00: Cost Reporting Requirements.

(2) Penalty for Noncompliance. The purchasing governmental unit may impose a penalty in the amount of up to 15% of its payments to any provider that fails to submit required information. The purchasing governmental unit will notify the provider in advance of its intention to impose a penalty under 101 CMR 320.06(2).

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Final Adoption March 19, 2021

101 CMR: EXECUTIVE OFFICE OF HEALTH AND HUMAN SERVICES

101 CMR 320.00: CLINICAL LABORATORY SERVICES

320.07: Severability

The provisions of 101 CMR 320.00 are severable, and if any provision of 101 CMR 320.00 or application of such provision to any eligible clinical laboratory provider or any circumstances are held to be invalid or unconstitutional, such invalidity will not be construed to affect the validity or constitutionality of any remaining provisions to any eligible clinical laboratory providers or circumstances other than those held invalid.

REGULATORY AUTHORITY

101 CMR 320.00: M.G.L. c. 118E.

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